Xcell Center Germany Journey

[dlbelbin]

Update from Barbara: X-Cell Center, the subject of much heated debate on this forum and other forums, was closed down by the German government. Thank you Germany!! This clinic was as bogus as they get.



My wife with TBI and son of 5 years old with CP have arrived in Germany. We are performing ASCT, bone marrow and return via LP. This is our third day here in Dusseldorf. As promised, I have documented our journey in detail at our blog http://www.belbinblessings.blogspot.com

We have arrived and did our first day consultation, second day we did their bone marrow extraction for both my son and and wife. Today is rest as the cells do their thing and multiply. Tomorrow, Thursday will be the return via Lumbar Puncture.

So far we are very impressed. The professionalism, efficiency, and cleanliness exceed most clinics and hospitals in the states. I can not compare stem cell clinics as we have only been to Xcell, but I can compare a clinic/hospital to a clinic/hospital.

One thing for sure, we need to do what ever it takes to get the US to approve these procedures.

I have had several conversations with Americans that have traveled here. We all have agreed that as we have these procedures done, that we must maintain communication and updates on patient progress. As we all have witnessed in our research, treatment results and progress drop off. I.e. no current updates 4-8-12 months after a treatment. I have spoken to Harrison?s mother, a boy in Denver that has gone to Xcell and she told me that they were very pleased with Harrison?s results and would recommend treatment. If I did not know her, I would have been lost with the rest of the folks looking into treatments. Understanding that we are human and more apt to report negatives than positives, we must continue to update either.

More later as we wrap up treatment.
David

[barbara]

Thanks David. I wish that clinics would do a better job of follow-up as well, but unless they are working towards clinicals or approval, they really have no incentive except for the fact it would help with future treatments of other patients. Personally, that would be enough for me if I were giving treatments. ICMS has a registry for patients and it has met with resistance from some doctors who really don't want to let others have access to treatment protocols that might help others. Doctors can license their technology, so it isn't as if they would be giving up proprietary knowledge as that would not be available in the registry. They undoubtedly also fear the registry would document therapy failures and heaven forbid if we don't all think that they have a 100% success rate.There is too much money to be made off of desperately ill people at this point to hope for the follow through that patients would like.

In the meantime, best wishes to you and your family and keep us informed.

[dlbelbin]

Well, it's complete. Both wife and son are asleep tonight after LP implantation this afternoon. The details are:
Wife had 20 vials of bone marrow removed. Then implanted 5.5 ml BMC solution containing 8,167,500 CD 34 cells with a Vitality of 80%.
Son Had 7 vials of bone marrow removed. Then implanted 4.0 ml BMC solution (high concentration) containing 7,180,000 CD 34 cells with a vitality of 71.6%.

Ideal Vitality that the center shoots for is 80% +. Minimum cells that they will put back is close to 2 million.

Wife had some discomfort of back pain this evening, but now is ok. Son acted as if nothing happened till the evening with very little discomfort. Other than that, a few days of relaxation with hopes they feel good in the morning, then off to the airport for our return home to Colorado.

Still very pleased and impressed with Xcell. Earlier concern we had was that Xcell did not return as much cells. Not the case. They put in what they get from the bone marrow..

The whole process from start (application) to finish (implanted cells) was great. Last step is for the driver to pick us up and take us to the airport.

Now its up to therapies and the ol' mighty. And the Cells to do their magic of course..

David

[Azriel]

Hi David

I'm watching your posts with interest, our son Oscar (three in April) also suffers from CP and the problem we have is that he will walk (walks with walking frame and trolley) and we expect will talk as says some words. Cognitively Oscar appears to be functioning as expected and the concern that we have is that with umbilical cord transfusion we are in for the unknown - unknown sources, unknown sex components - and we have a son that has a lot more to loose than some of the other families who have much more severely disabled children that we have met who have taken the treatment. Life expectancy for some of the other New Zealand based children has been early teens whereas Oscar does not have that as an issue and we fully expect him to have a normal length of life.

It is a shame as I have literally returned yesterday from Europe and flew in and out via Frankfurt and was in Brusells and Bern so not all that far given we are the far flung reaches of New Zealand! Had the dates been a little different I would have been stopping to see Xcell. However, I really do wtch this with interest as if you get improvements from the bone marrow treatment we will be off to do the same.

Kind regards

Merryn

[dlbelbin]

Good day to you Merryn.
We had the same concerns in regard to UCB cells. Duke University did a trial with kids using their own UCB cells and found great success. In conversation with Denise from New York who was at Xcell mentioned that they are looking into using sibling UCB cells. He had saved his latest child UCB and checked into using those cells for another child. At this point, that is a no. No doubt that UCB cells are the best if they are your own. In readings on donated UCB, they have narrowed the gender etc when choosing cells to use but still no guarantee and still in study. Rejection etc percent is higher when using any donated cells. In conversation with doctors here that will follow up with our sons treatment also had concerns with donated UCB cells. As you mentioned, depending on the level of symptom, one must measure the amount of risks/failures/possible success/monies in their individual equation of what, where and who.

With the monies and theories involved, we chose Xcell. In the beginning we looked and asked for results from families that have been to Xcell with little to no response. It was not until I started to direct emails straight to the source, calling families that we have meet here in Denver that have gone i.e. Harrison and Dominique and finding a lot more blogs of families, that we got what we were looking for as to results.

Looking at Kaci?s Mom posts, they have done well with good successes using UCB. You may want to take a read on her posts.

As to did I choose right and know everything that there is on the subject would be a no. I am confident that I smothered the subject pretty well in the past year. Did I choose right by seeking this treatment, absolutely yes. Do I feel comfortable with the treatment received, absolutely yes. Now, it is results time.. Can not wait to see how it comes out.

I?ll do a recap and finish off our visit and add some travel notes in the next day or two. My body and mind needs to catch up with time and space.

Good luck and let me know.

Have you started a blog? If so, let me know.
David

[dlbelbin]

For those that have interests in Xcell, these are my tid bits and process as to how we experienced them.
1. Apply on line. Fill in medical history.
2. A Xcell consultant assigned to your region will contact you. USA clients will have a USA consultant, Japan will have a Japan consultant. Makes sense as we all speak different languages around the world. The consultant will request copies of medical documents and a current MRI or other. The consultant communicates with the doctors in Germany. The consultant will come back with an approval or no approval for treatment. This process is the most time consuming. If you need to make MRI appointments, medical appointments etc.
3. Once approved, you tell the consultant what dates you want to start treatments. The consultant gets back to you on treatment dates and times. You will have a deadline to tell the consultant: Yes, these are my flight times and this is how I will pay for treatment. I recommend International Bank Draft. Our bank did not know what IBD was till I insisted that they need to figure it out. Which they did. Do not make flight and travel plans till they tell you to.
4. Ask your consultant your questions. The consultant will get you your answers. Communication with the doctors is ok as we witnessed with others.
5. The consultant will send emails with a bunch of attachments. The attachments are forms that you will be filling out once you arrive to the clinic. Do your homework and read them. While at the clinic, things go fast and you will be able to fill out the forms quickly and comfortably.
6. You will have the option to use Xcell transportation or your own. You will need to communicate to the consultant your transportation plans. They charged 150 Euros, which we thought was priced high at 220 US. After riding in a taxi to our hotel, the math turned out to favor the Xcell transportation.
7. The consultant emails dates, times, and a scenario of what to expect. Our consultant gave us a scenario from getting of the plane, airport checkpoints, looking for our driver, to the ?T?. He was precise.
8. Stick with the consultant! We had a change in our consultant mid way through the process and stayed in communication with the new consultant. They did a good job through the transition.
9. The consultant stays with you up to the day you leave and give?s you a farewell email with contact information and dates. Till that point, stay with the consultant.
10. Done with the consultant. The rest of the communication will be directly with the clinic in Germany.

Very simple and smooth. The longest time taken is making appointments and getting MRI?s completed, last minute follow up surgeries, etc. It took us about 3 months. Remembering that I have had 2 family members to get completed.

The next is all in Germany.
Day 1 for children is meeting with the anesthesiologist. Day 2 is the bone marrow extraction. Day 3 rest and wait anticipating outcome of cells. Day 3 you will have time to tour and play. Day 4 return of stem cells via LP. Day 5 and 6 rest and drink plenty of fluids. Kenneth and Reyna were not up to much but to hang around the hotel. Day 7 return home.

I suggest that you request for extra Vomex. Vomex is the nausea vomiting medication. Take it prior to take off for the flight home. Critical?. We learned the hard way.

We enjoyed our hotel. Lots of space. If you like spending 3+days lying around a small hotel room, you will have lots of choices. We did struggle with finding a hotel that accepted 4 to a room. We meet a Mother with her daughter that stayed at Mercer and found the room very small and uncomfortable. We spent almost 2 weeks looking for a hotel. Google earth works well. We used Google earth so much that we felt like we knew where everything was when we arrived. DVD?s and more DVD?s. Hotel TV is like antenna channels all in German.

Meals. Germany is pretty much closed on Sundays. Sundays for the majority is arrival day. Shopping and grocery stores are closed. They do have gas stations with snack/sandwich items that are open. I would suggest packing up some of those add hot water meals. First day arrival supplements that will hold you over till you can get to a restaurant or the hotel opens its restaurant. Take it from grandma, pack up foods. After a 16 hour day flying, those little meals came in handy till we figured out what we were doing. When you?re exhausted, this can be challenging. The driver told us a story of a family that found them selves taking a taxi to McDonalds and back. It cost them well over 50 dollars. The hotel food is expensive. We did do some grocery shopping which was very economical. Our driver also stopped at the gas station for us so that we could pick up additional snacks, sodas etc.. Between the clinic and hotel. If you stay at a hotel with a continental breakfast, make sure there is a restaurant or store near by.

Take smaller bills like 20?s with you. Our hotel would not exchange 100?s to Euros. The banks will take 100?s to exchange.

The last and most important is my 6 P?s. Proper Planning Prevents Piss Poor Performance. Get ahead of your planning and arrangements prior to leaving. Last minute things could happen and make the leave a stressful one. I.e. I had a sinus infection that turned out to be a root canal and sinus infection the week before we left. On top of that, I do work as well as all of you. I think this made our departure pretty stress free with everything covered 2-3 weeks before leaving. As we all know traveling with special needs is and can be stressful. Better to be having a martini at midnight before the flight instead of running around trying to get things together.

I think that?s it. I hope this helps. I am sure all experiences will differ.

I invite any one and everyone to add to this. I know one thing for sure; I wish I had this kind of information prior to leaving. That is why I have written.

[barbara]

Thanks for the info. I got tired however, just reading it. Hopefully, you will get some results so as to have made all of this worthwhile. I have never had to go through all of what you described. Thank you for bringing us up to speed on the way things are done in Germany.

[michaelsdad00]

David,
I am astounded at the detail with which you have described the treatments. My son has received 5 sets of UCB stem cells over the last 6 years with mild improvements for his cerebral palsy. We are moving closer to having him receive autologous stem cells either through arterial catheterization or possibly a lumbar puncture. Thank you for posting all of this information.
David Snow

[PJeannine]

I am Grandma P. Jeannine Headrick who traveled to Germany with my son David Belbin and his family for adult stem cell therapy. I have been caregiver to Kenneth since his birth in Aug 2004. I would like to add to David?s ?tidbits? of the trip and what we learned from other families there.

Be sure to get baseline testing done. Children?s Hospital in Denver was very supportive in ordering Kenneth?s MRI, blood tests, CP clinic, Gait/motion Evaluation, neurological/psychological ?Mini-MORE? testing (Multi-disciplinary Outpatient Rehabilitation Evaluation), and also expedited his surgery for closure of his Gastrostomy opening. (He had been G-tube fed for over five years). Reyna?s doctors at Craig Rehab and her neurologist also expedited her MRI and testing.

Apply for passports well in advance. Even if you are unsure you will be traveling abroad. We became acquainted with two families that had to reschedule travel and clinic appointments due to delay in receiving their passports.

Dusseldorf is a trade center with many events all year. Our trip coincided with a trade fair which might possibly explain why our search for an appropriate location took longer. The Holiday Inn in Neuss (pronounced ?noose?) was an excellent choice. We had a moderately priced one bedroom suite with a kitchenette including a mircrowave and refrigerator. I found the sofa hide-a-bed in the living room quite comfortable. We had earlier decided against the added expense of the continental breakfast. At 17 Euros per person each day, a total of 496 Euros or $678 US, we felt that we couldn?t possibly eat that much breakfast. And, also our patients would not necessarily want to be up and about that early. Since we had the kitchenette, we came prepared with instant oatmeal, instant coffee tubes, instant juice flavored drink (especially useful during travel), small boxed cereals, EasyMac, and dry prepared meals to mention a few. And, yes, I still had room for my clothes. LOL

I had a solitary walk into Neuss on Day 3 while Reyna and Kenny were resting. I found a visit to the Cathedral very uplifting and my timing was perfect for an 11 AM view of the ?Glockenspeel? performance in the church square . Sadly, my later trip into the Marketplatz with the family did not coincide with the next performance for them to view. The Cathedral is the one shown in the Neuss.de webcam.

I was extremely impressed with the professionalism at Xcell Center. Also, with airport security, customs, immigration, passport control, and Delta personnel in expediting all processes for those with special needs.

I want to thank all of those who contributed to us - emotionally, mentally, and financially, and especially to those who have and continue to pray for our loved ones. God bless you.

[barbara]

Nice to hear from you Grandma. In the case of Germany, patients must spend extra time in the area due to their cell processing. I think it would do every patient good to slow down a bit and not rush home the very next morning after treatment as many do. Many offshore clinics are now incorporating stays of 2 weeks or more to their protocols in order for patients to get more R and R and I think it's an excellent idea. In Europe that might add too much to the cost, but in the Caribbean for instance or Central America, it would be quite affordable for patients.
It is an emotional experience for most (especially if it is the first treatment) and it can be stressful so being prepared is helpful as is taking it easy afterward. I have had smooth sailing with all of my treatments except for the first one and have always been treated in a professional, courteous and caring manner. Any clinic that does not provide that is certainly one to avoid.

[dlbelbin]

Link to Denver 9 news article on the two Denver Boys that went to Xcell last year.

http://www.9news.com/news/article.aspx?storyid=134257&catid=188

[dlbelbin]

Hard to believe that 33 days have past. We have been waiting to update after an appointment with Kenneth's doctor. We decided to postpone the appointment a few more weeks out from the treatment.
Kenneth has been a lot more talkative and focused. Perhaps one can call it cognitive improvements. Pre treatment he was on 1.5ml x3 daily of baclofen. We decided to take him off prior to treatment. As of today, we have not put him back on and his tone has reduced. Pre treatment he was ready for another surgery in his legs, now with the reduction of his tone while not on the baclofen, it will be interesting to hear what the rehab surgen has to say. His therapists agree that he is more cognitive and has a lot less tone than pre treatment while on the baclofen. He is also more willing to do tasks and therapy walks in his walker. His thumbs are less pronounced inward and while making fists. Less compulsive and involuntary movements.

My wife Reyna has shown changes. Pre treatment she had a "deer in the headlight" look and would say "what" as she first would not understand or unclear of what was said. Also, she would have multiple projects going on around the house half completed. I have not seen this since we have been back from treatment. She seems a lot more focused and on the ball. Just a lot sharper and on a mission around the house or while shopping. Her balance has improved as well. Also her texting has improved. In the past she would send me a text message that would be sum what garbled. I would have to call and do the yes no questions to get the answer. Now they have been precise, i.e. " buy tortillas yogart bread milk".

Strange how these things just can change in a short time. We still have a long way to go, but I am waiting to see what the next few months bring us.

I will update after a visit with the doctor. These doctors are the ones that have been following and tracking other ASCT kids.

Our improvements seem to be consistant with others. Here is a cut out of an email from a parents doctor out east. East from us that is..

" Thank you for all the useful information. We were at Childrens Hospital of Philadelphia on Thursday, our muscle skeleton doctor has had three kids go to Germany and three kids participate in the Duke program - what she stated is that the younger the child, the more results they are seeing in both cognitive and motor skills, the older children are seeing most improvement in cognitive areas. All good news to me- all of the kids had marked improvement."

Other than that, still looking forward to new things that will arise.

David

[michaelsdad00]

Thanks for posting your update...

[dlbelbin]

Met with Kenneth's doctor today. It is noted that Kenneth's tone has decreased and we will not put him back on baclofen. Kenneth's tone is lesser than prior to ASCT while on baclofen. Range of motion has improved a lot. They do believe (although no scientific proof) that baclofen may interfere with the neuro development and process of ASCT. Also, we have decided to refit Kenneth with hinged AFO?s.

Spoke with Kenneth?s teachers and para today. All three have stated that Kenneth is more calm, relaxed, and starting to use his pincher fingers in doing tasks as trying to write and picking up small objects. They feel that Kenneth has made progress and improvements since ASCT.

Summing up an improvement cognitively and reduced tone and fine motor skill development.

I can?t wait to see what?s next and what time will bring us. I find this "scientifically not proven" procedure very interesting and very rewarding.

David

[michaelsdad00]

David,
It has been 7 or 8 weeks since we spoke and I am wondering if you have seen stability of any improvements or even an increase in improvements in your son, Kenneth?
Thanks,
David Snow

[barbara]

I would also like to know how your wife is doing. Thank you.

[dlbelbin]

Update on progress. May 23rd. 3 months post ASCT.
Our son Kenneth continues to show progress. Nothing big at this point. Cognitive, fine motor and tone have shown the most improvement. Cognitively he just continues to amaze us with his skills. Although those skills could be acquired from learning in kindergarten but you never can tell. He always has done well with vocabulary and reading and is currently reading at a first grade level. He still has opportunities with a few letters like ?S? and ?Z?. He continues to talk, talk, and talk. Fine motor skills continue to improve. He uses his pinchers more and more when tasking with small objects instead of ?palming?. He is getting better control of bicycling with his legs. Tone, huge improvement. He has not been on baclofen since February. No sign of putting him back on it either. A few weeks ago his tone seemed tighter but then loosened up again. Therapists are all very happy with Kenneth?s improvements. All in all, very pleased thus far with what and where he is in his progress.

My wife Reyna continues to show some progress. Not as quick or as much as I would like, but some is better than none. I think her improvement is mostly cognitive. Focus, thought processing, organizational skills and balance have shown improvement. Nothing significant or perhaps very significant depending on how you look at it. From my readings, it looks like TBI patients will show slower progress if any. She believes that she has had no changes but I can see changes. She is like the energizer bunny; she just keeps going and going, from one project to the next. Pre ASCT she would not complete the projects. She would have 5 projects going on at the same time, not completing them and being frustrated. Post ASCT, she completes her projects then goes on to the next. We have seen very, very little physical improvement. I.e. use of her right hand and tone. Phone texting continues as earlier noted. Understanding that she had a great deal of damage and injury to her brain affecting those abilities, it may need more time. We are pleased with her progress thus far and hoping for continued improvement.

Like many situations, 5 steps forward ? 2 back then 5 forward. Post ASCT, the forward steps are just more significant. 10 forward, 3 back then 10 forward.

What we all do, what we all strive for, why we do all the things we do can be summed up in a story told by Zig Ziglar in ?How to Get What You Want?. Zig talks of a boy named David Latzy(spelling) who had CP. I find it an appropriate story for why we are all here. Finally found it?

David

[michaelsdad00]

Hi David,
Last February, you expressed an interested in keeping the lines of communication open after the stem cell therapy. It has been awhile since I have heard from you. Any Positive, Neutral or Negative information you are interested in providing on your son's Post X-Cell Institute SCT treatment?
Thanks,
Dave Snow

[michaelsdad00]

We received approval for my son's treatment from XCell Institute in Germany the other day. Not too long a wait for a reply. Probably a week or so. We are starting to make plans for next summer so we can take our other two children with us. Anyone else on this forum who has received a stem cell therapy from them please feel free to pass any information on to me if you wish. I'll have to re-read David Belbin's narrative again.
David Snow

[barbara]

Did you ever hear from David? I don't believe that anyone is turned down, so not exactly sure what "approval" means.

[hislim]

I have been tracking this blog for some time now, hoping that I will get some objective feedback from those who have tried the xcell center treatment. If you have personal experince with their treatement ... I seek for your feedback. Please I am "Desperate"

[dschroed]

Hi - I have had positive feedback from 3 people living in my area who took their childrenn for treatment there. 2 have cerebral palsy and 1 had a very bad car accident. All three are doing much better after treatment and said it was well worth the effort to go. They all were referred by friends of mine and not solicited by the center. In fact, none of them are listed in the patient stories. I am going in a couple months and will share my experience on this site. I want to help others as I know it is tough finding the right clinic. I know that none of them have autism, and I have MS, but I hope the general experience comments can help.

[barbara]

The X-Cell site claims they have treated over 3500 patients, so the percentage of patients in the Patients Stories part of their website is very low.
If these are close, personal friends of yours and not friends you met online, then this is some good news. But if not, I would have to discount such testimonials as having no more credibility than other online testimonials.

I trust you to give us some good reports as to what you might get from the treatment so please keep a diary if you will before and after treatment. MS is getting highly treatable so I wish you all the best. Some real progress is being made I believe with it.

Hislim - An ongoing topic on this forum is X-Cell and the lack of any quality information coming out of the clinic. I have no idea if patients think this is the only clinic in the world, but the topic just keeps coming up. The fact remains, this clinic does not cooperate with groups such as ICMS, will not participate in the Ask the Doctor on our forum and engages in a brilliant marketing strategy of fancy press releases all over the internet. Patients that go there and promise to return and report their experiences usually do so for such a short period of time, that we are all left wondering what happened to them.

I do think the popularity of this clinic is the image that Germany is a country with higher standards than some other countries, the price, and as I already mentioned the total saturation of the internet with their ads. It can't be results, because they publish no papers nor conduct any clinical trials or studies that I am aware of. They are not in the ICMS patient registry either.
That leaves us with the "parents" of patients who are pleased with the results and other vague reports of a friend of a friend who went there and was "happy". That sure doesn't help me any if I was trying to choose a clinic to go to, but it must work for others because X-Cell continues to enjoy a great business based on nothing more than advertising it appears.

[michaelsdad00]

SCT protocols,
It comes down to who you trust based on what is being done. The stem cells will either be derived from Umbilical cord blood (your own ideally) or your own stem cells either taken from skin, bone marrow (blood) or Fat (Adipose). If these stem cells are expanded in the quantity and is the quality improved by neural or other bioengineered safe growth factors to improve the quality of the transplanted cells, that would be Great! Also, one has to be comfortable with the safety of the medical delivery procedures. An injection beneath the skin, intravenous, intra arterial catheter, intrathecal (spine) or a direct implantation say directly into area to be affected such as the brain. The cost and risks involved with the safety of the handling and source of the stem cells and the medical transplant procedures are what it is all about. It would be great to see a chart with these all listed out but when you start to try and tease out what is being done and the other details it is hard to compare all of the different clinics. If there is a clinic that is expanding the quantity and quality of stem cells and delivering them the most effective way based on the condition being treated that would be ideal. In looking around now it seems that XCell may be just harvesting and reinjecting the stem cells from your bone marrow. It feels like a safe comfortable environment and they aren't charging an arm and a leg to do it.

[barbara]

If that's all they are doing, if they are charging over $10000 US, then they are charging too much. Even that is being generous and assuming they have hard costs such as a hospital room, anesthesiologist and a doctor or two. Of course, other clinics overcharge as well, so I can't single X-Cell out for wanting to be very profitable. Does anyone realize how very little goes into a treatment such as Dave describes? Even paying doctors $1000 per hour doesn't justify some of the prices being handed out to us for treatments. Add on airfare, meals and hotel and it is a serious chunk of change we are paying.

Hislim - There are risks in any procedure that requires anesthesia and is invasive. X-Cell's treatment or the treatments given by other clinics that use anesthesia and extract from the marrow or do lipo are not risk free. Some scientists would argue that the treatment itself (the stem cells used) is not risk free, although I argue back that the disease I have is far riskier left untreated without stem cells than it is treated with my own stem cells. There are ZERO guarantees with stem cell therapy of any kind. If something does go wrong, you aren't going to be able to sue the doctor or the clinic. That friendly sales rep or nurse or clinic owner, will not be so kind as to even return your frantic phone calls most likely. Make sure that the anesthesia is one you can tolerate (or whoever the patient is). X-Cell is like any other clinic in the world and mistakes can happen. One patient reported he was left under anesthesia for over 3 hours for his marrow extraction at X-Cell. Take someone with you that can be the watchdog. Make sure that the marrow is processed properly. Ask a ton of questions BEFORE you go. If there is any hesitation or you can't get answers, don't go. There is no way to evaluate safety or efficacy from a website. I hope someday to see treatments become more affordable because the more comments I hear from members about X-Cell, it seems that price is one of the biggest factors.

What a shame that we are forced to go offshore, spending hard earned money to try to save and improve our lives. We go with little information, no guarantees, no opportunity to have things righted for us if something were to go wrong. We don't know if what we read is true. We don't know what kind of treatment might be best because every clinic says their treatment is the best. Can you understand why I advocate for science based studies, clinicals, and/or the use of the ICMS patient registry? Those are all tools to help us and clinics that will not and do not want to do any of these things will remain suspect to me. Believe me, it doesn't take much to ask your patients to become a part of the ICMS patient registry. At least it is a sign that a doctor or owner of a clinic believes that his own treatments have some efficacy.

I hope you have signed the petition if you feel the same about the precarious situation the FDA has put us in.

Here's the link for those that might have missed it.
http://www.thepetitionsite.com/1/PetitionforAdultStemCells/

[hislim]

I understand what you are all saying ... but the news that I am following gives so much hope that I just want to belive it. I know we are missing the scientific facts to support their (xcell) claims but that is why I am hoping to find a person with a first hand experince to what was offered to them bby xcell.

[barbara]

And what I am saying is good luck with that. You won't find it on this forum. If something sounds too good to be true, it probably is. No treatment that I know of is going to work on 100% of the patients that get it 100% of the time. I'm sure that not even X-Cell would dare to boast something that outrageous. From those that actually post on this forum and from personal e-mails I receive, I am going to estimate that about 50% of patients see improvements after their first treatment. That's just a rough, unscientific estimate. Improvements also include stopping the progression of their disease. Getting nothing from the treatment or finding a company is bogus, is a risk, I'll agree. That's why I support the efforts of ICMS and their offshore directory and most importantly, the patient registry. The registry will also be of use to doctors to see what type of treatment might benefit certain diseases the most instead of just hit and miss and let's hope it works or the one type fits all that is popular at many clinics. Being sick or having a child or loved one that is sick does make us take more risks. Some companies and doctors take advantage of that.

[pink7]

I understand what you are all saying ... but the news that I am following gives so much hope that I just want to belive it. I know we are missing the scientific facts to support their (xcell) claims but that is why I am hoping to find a person with a first hand experince to what was offered to them bby xcell.

If you are looking for some significant benefits for Autism with stem cells, it is better to look at other stem cell centers. Check Cellmedicine in Panama, they have treated lots of Autistic children.Stem cell treatment alone is not going to help the child.Biomedical treatment, HBOT, ABA and speech therapy will help the child.

All the Best

[barbara]

Excellent advice Pink7. I think this is going to be true with many diseases. It is going to take a combination of therapies, not just stem cells and not just one treatment. Too many people are banking on a magic bullet. I wish this were the case, but in most cases, it just isn't going to be that way. Notice I said most. This is not a hard and fast rule by any means as there are some conditions that do respond very quickly to stem cell therapy alone.

[barbara]

http://www.translational-medicine.com/content/pdf/1479-5876-5-30.pdf

Here is the published paper from CellMedicine on autism. Hislim, I hope you will take time to read it so that you can compare treatment to that offered by X-Cell and any others that you might contact.

[michaelsdad00]

Excellent Website. Thank you for posting it.
Dave

[dschroed]

Barbara - they are personal friends who know these people. One child with CP has had siezures subside significantly after treatment. This family lives less than five miles from where I work. Xcell has more current info than Biogenisis, at least what I can see, and they are involved in clinical trials with the French with spinal chord injury (on their news page but I did veryify it is true). I am currently waiting for information from someone who works at a Central American clinic that has posted peer review literature and has performed treatments on over 200 MS patients.

[barbara]

dschroed - Not sure how Biogenesis has now creeped into this discussion, but if you have information that the clinical trial for sci has actually started, will you please post it? I did see a safety study that was posted. X-Cell was criticized recently (by a group in the UK) for not having such a study, so if the criticism of this company by others can bring about much needed change, then that is a good thing in my opinion. There is absolutely NO reason with the volume of patients they get that they are not doing clinicals and studies. That is and has been my point all along.

Thank you for chiming in.

[hislim]

I do not mean to change the subject ....
I was following, very closely, David belbin story but the last time he gave an update was last May. He was very excited about giving feedback and updates but since May he stopped. I hope this is not a bad sign of disappointment. Anyone knows anything about him and his wife and child who had the treatment at the xcell center back in Feb.

[barbara]

I did a Google search for X-Cell and Dr. Kleinbloesem who started the clinic. I have put several links below for you to read through. When you finish, Google some more and you will find more of the same kind of information that I did. I did find that back in 2007, Dr. Kleinbloesem was indicating that he would be doing some clinical trials very shortly. It will soon be 2011 and I couldn't find anywhere that any trials had begun. I tried to find more on the study in Crete, but the links always come back to the X-Cell site. One of the trials is supposed to be for CP. There are mixed feelings on the boards about whether treatment did anyone any good. I did find that some patients featured in the Patient Stories were also the same ones that did a lot of posting (cheer leading I should say) on the boards. Is this a good or a bad sign? You be the judge. It is very easy to plant paid people on boards and forums. The Pioneer forum was actually victim to it once with someone from Medra.
My conclusions after reading all I could stand are that this clinic is masterful at recruiting patients, writing press releases and maintaining an image of scientific integrity when there really isn't any. The odds of seeing a few bodily functions improve with this type of therapy aren't that bad, but actually reversing disease or having an sci patient walk again, I just don't buy into it.
At least it doesn't sound like very many people are getting ill after treatment there which is a plus. Better to have treatment with zero results than to have treatment and become seriously ill from it.
As for David Belbin, I wish he would update us too. Just read through the sites I gave you and that is very common with others. They are enthused at first and then others post asking how they are doing and there is no reply leaving readers to wonder whatever happened to them. Since, X-Cell is totally unfriendly to this forum, I have no way to ask any questions of them. There is nothing in the ICMS offshore guide to help either.
As I have stated before, I would not spend any money getting treatment from this clinic.


Here is a statement from their site promising clinical studies by this year:

The XCell-Center combines clinical expertise with scientific research.
For 2009 - 2010, we plan to initiate two international clinical trials, one for Spinal Cord Injury and the other for Cerebral Palsy.

In 2009, we've commenced a study in cooperation with the University of Crete: "Stem Cells in Diabetes Mellitus Patients with Limb Amputation".

In addition to clinical trials, we also perform pre-clinical research projects
These projects involve second and third generation stem cells. Second generation stem cells will enable us to multiply mesenchymal cells (multiple treatment option). Third generation stem cells will allow us to target specific cells (multiplied targeted progenitor cells, f.e. progenitor neuro-cells).

These projects are developing in close collaboration with Neuronax and the University of Clermont Ferrand in France.

Here are some sites where others have posted their experiences.

http://tiny.cc/m9hjn

http://tiny.cc/fbxjd

http://tiny.cc/my2c2

http://tiny.cc/gc9aw

http://tiny.cc/7ixxv

http://tiny.cc/utevg

[dschroed]

Barbara - the french site I found the clinical trial information on was a posting by X-cell, so my earlier post was mistaken. I am still actively persuing treatment there at this point.

[barbara]

Are you planning on the Liberation therapy and stem cell therapy or just one or the other?

[dschroed]

Just stem cell at this point.

[barbara]

Thanks, I was just wondering.

[PJeannine]

I am David Belbin's mother and went to XCell in Germany with them for ASCT for both his son (CP) and his wife (TBI). He has been in "work overload" and unable to catch up with blogging. (I have nagged him, as only a mother can). I cannot speak for him, but I can report my observations. The end of August 2010 was six months since treatment.

Both Reyna and Kenny have had significant cognitive improvements. Most apparent in Reyna as she had more problems in this area than Kenny. Her eyes are brighter and her laugh more spontaneous and appropriate with major improvement in comprehension.

Reyna's speech has improved but is still primarily limited to about 20+ most commonly used words. David is looking for a speech therapist. Her gait and use of right limbs have improved. She walks much more smoothly. She is now able to care for Kenny with only an afternoon CNA. I had been primary caregiver since Kenny's birth. This has been an amazing change in all of our lives. I am now only needed to put him on the school bus in the mornings. (Anyone want to talk about separation withdrawals? LOL).

Prior to treatment, Kenny was on Baclofen and his Ortho-surgeon said he needed a second surgery to lengthen his abductors and hamstrings with additional BOTOX/Phenol. After ASCT with reduction of his tone, his legs were weaker as he was used to the tight tone. He is slowly increasing his muscle strength and distance he can go in the walker. At this time has still not needed Baclofen, surgery, or BOTOX/Phenol. Since I am not with him during the day now, his fine motor improvement is difficult for me to determine. His OT and school Para have stated they thought the major improvement was in his behavior/concentration/attitude. Where before ASCT he was unwilling to try to do the work because he felt he couldn't do it, now he is trying more. Hard to say if this is cognitive or fine motor improvement. Possibly a little of both.

Are we disappointed in XCell and ASCT? Of course, we are human and wanted complete "cure". Are we satisfied that it was worth it? Definitely yes! Will we be going back for more? Yes, probably early next year. It is unfortunate that XCell doesn't post more trials and stats. But, this should not deter anyone from investigating treatment for themselves or those they love!

Disclaimer: All the above is only my own observations. If anyone wants to contact me.... please do. I wish everyone the best.

Grandma Jeannine Headrick

[hislim]

Thanks PJeannine for this update ... this is promising as far as I am concern. I do not look for a cure, I know I won't get it, I am looking for an improvement and hopefully to build on top of that with therapy and so on.

[PJeannine]

Hislim,

You are welcome. We weren't expecting a miracle cure. Our family member's conditions are not as involved as some and their improvements seem to be in ratio to others that we know here in CO that have gone to XCell.

Good luck and keep the faith and the fight!

P. Jeannine

[barbara]

Thanks PJeannine for the report. I would now like to put this thread to rest.
Your post makes it very clear that patients must approach therapy at this point in time without expectations of a cure. I have mentioned many times that expecting beyond what this type of therapy can deliver is not realistic and will only result in major disappointment for patients. You sound like you have an optimistic attitude and this is what it takes to enjoy the improvements that you feel were a result of the therapy for your family.

I do hope that everyone that reads this will support our fight to make stem cell therapy widely available in the U.S. There is absolutely no reason that patients in North America should have to travel all over the globe for over priced, unproven treatments that should be available close to their home. I direct this at all clinics that are guilty of this, not just X-Cell. I may sound like the ISSCR when it comes to what I just said, but the ISSCR offers no options for patients, whereas treatment in the U.S. using specific guidelines that the ICMS has set in place, does offer options. Offshore clinics that conduct their own clinicals are also on track with what is needed in this industry. Patients deserve this and when we don't ask for it, we won't get it. It is a real statement however, that with a membership over 1100, that few have bothered to sign the petition. Apathy abounds.


http://www.thepetitionsite.com/1/PetitionforAdultStemCells/

[alex]

Thanks for this update. Hopefully, you'll see more improvements yet in the months to come.

[Kaci's Mom]

Thanks PJeannine for the report. I would now like to put this thread to rest.
Your post makes it very clear that patients must approach therapy at this point in time without expectations of a cure. I have mentioned many times that expecting beyond what this type of therapy can deliver is not realistic and will only result in major disappointment for patients. You sound like you have an optimistic attitude and this is what it takes to enjoy the improvements that you feel were a result of the therapy for your family.

I do hope that everyone that reads this will support our fight to make stem cell therapy widely available in the U.S. There is absolutely no reason that patients in North America should have to travel all over the globe for over priced, unproven treatments that should be available close to their home. I direct this at all clinics that are guilty of this, not just X-Cell. I may sound like the ISSCR when it comes to what I just said, but the ISSCR offers no options for patients, whereas treatment in the U.S. using specific guidelines that the ICMS has set in place, does offer options. Offshore clinics that conduct their own clinicals are also on track with what is needed in this industry. Patients deserve this and when we don't ask for it, we won't get it. It is a real statement however, that with a membership over 1100, that few have bothered to sign the petition. Apathy abounds.


http://www.thepetitionsite.com/1/PetitionforAdultStemCells/

I agree and disagree with you Barbara. I do so agree that we SHOULDN'T have to travel all over the globe in search of a clinic that treats with autologous stem cells!! But for many of us, we are dealing with younger children. Finding a clinic even willing to treat them due to their age seems to be the BIG problem.
With that said, I disagree with "putting this thread to rest". Currently I am ALSO in pursuit to find a clinic that will treat Kaci with her own stem cells. Yes, X-Cell might be an option, as might Cell Medicine, and maybe some place in India. None of which I am very excited about because of the traveling aspect. But clinics closer to home (Mexico comes to mind) seem to steer clear of bone marrow extractions when it comes to kids- if it's so simple, what's the big deal? Is it because some of these clinics base their customer relations within the United States and worry about liability? I think it would be AWESOME to just run down to California with Kaci to do a autologous treatment while it's still NOT illegal. But at this point, unless she's an adult, we're forced to choose from the few offshore clinics that advertise.

SO... EVERYONE WHO HASN'T, PLEASE SIGN THAT PETITION (so we don't lose complete freedom of our bodies)!!!

Kristin

[barbara]

It's a good question and one that I will be happy to submit to next month's Ask the Doctor. As for the liability aspect - Most Mexican clinics ask for the money to be wired to Mexico or even another country other than the U.S. because of the liability situation. If you do not pay for the treatment in the U.S., there really isn't a liability that could be pursued in a U.S. court is what I am told. Since all stem cell treatments are experimental, no one wants to be held responsible for things that can and do go wrong. Any treatment we have is at our own risk, but as I have often said, my disease is risky if I do nothing just by the progressive nature of it so which is the worst choice?

The reason I prattle on about clinicals and studies is that it would take a huge burden away from patients who may only have funds for one or two treatments to know if there is efficacy to the treatment or if it is just a shot in the dark based on what some other patient said or what a website touted.

That's not very good service for treatments costing thousands and thousands of dollars, but patients are desperate and clinics know that so nothing needs to change unless we make it clear we want that change.

Have you checked with Stem Cells for Hope? I know that the CEO indicated they were accepting CP patients, but we haven't had any feedback from anyone who took their child there and I do not know if they are doing any studies either.

Thank you for supporting the petition.

[Kaci's Mom]

OK, but all 3 times we've sent payment for Kaci's treatment to a company in the US (California too be exact). Which is why I wonder, if they (you know who I'm talking about Barbara) aren't worried about liability with umbilical cord stem cells by taking my check right here in the States, that surely can't be their only concern when it comes to autologous treatments on children- right? We also had BIG hopes ("we" meaning myself and others on the forum) that Biogenisis Institute would be the next GREAT place to go that's fairly local. But they even seem to be shying away from treating kids.
Kristin

[Kaci's Mom]

Sorry to bring this back, but...
I emailed SRI this morning to see what was "new" as far as treatment using autologous stem cells. I got a call back this afternoon from them. In response, Dr. Steenblock doesn't do bone marrow extraction on small children because they tend to move around- apparently NOT something you want happening. Dr. Steenblock also doesn't use general anesthesia in his office, which would explain not working on small children. However, I was informed that Dr. Ramirez WILL do this kind of procedure- either by extracting the bone marrow, separating the stem cells and putting them back in, or extracting the bone marrow, multiplying the cells for 2 weeks, then putting them back in. Seems in a way kind of simple. What are places like X-cell and Cell Medicine doing to the stem cells after the bone marrow is taken out?
Kristin

[barbara]

I was sent this from a very reliable source. Much of what is stated here is exactly how I feel about this company. I would have to say Buyer Beware.



Translation of an article from WirtschaftsWoche, No. 16, 19.4.2010
The Hope Business11 diseases can be alleviated, XCell doctors believe, using their method 26 000 euros is the cost for Parkinson?s patients to have stem cells injected into their brains.
2900 treatments have been carried out already, XCell claims
Doctors want to cure heart disease and diabetes with stem cells. However,
companies are trying to lure in the seriously ill with exaggerated promises of
medical cures, before the benefits have been confirmed, jeopardizing human
life.
The pain returned during snowboarding - J?rn Bethge?s* right knee ruined his
holiday. Eight years previously, the 31-year-old?s knee cartilage was smoothed out in
an operation. Now, he?ll have to go back under the knife, says his orthopaedic
surgeon. However, he is also advising him to put the operation off, because this
procedure cannot be carried out over and over again. Otherwise the cartilage will run
out. Bethge had a better idea. In the internet he came across a new therapy which is
being offered in Duesseldorf, Germany. This therapy enables the torn cartilage to
regenerate itself with the help of stem cells. At least that is what is promised.
Making this truly incredible offer is the XCell-Center which has set up shop in the
Dominikus Hospital in Duesseldorf-Heerdt. Bethge made an appointment there and
also asked about the risks. He was told by one of the staff that the company has so
far carried out 2900 such treatments. And whether it was the knee, the heart or the
spinal cord, XCell?s stem cell therapy has never resulted in any complications.
The parents of a ten-year-old boy, who was recently admitted to the Duesseldorf
University Hospital, might want to tell a different story. XCell staff extracted stem cells
from the boy?s hip bone marrow and later implanted them into his brain. That was
supposed to alleviate his epilepsy and the resulting developmental disorders.
However, a few problems arose. The boy nearly died of a brain hemorrhage.
Although, the University Hospital doctors were able to save him, he is now even more
severely handicapped than before the XCell operation.
Footnote
----------------------------------------------------------------------------------------------------------------
* Name has been changed.
-----------------------------------------------------------------------------------------------------------------
In answer to a question from German magazine, the WirtschaftsWoche, Stefan
Kempfen, a spokesman for XCell replied: ?I know of no complications arising from the
treatment.?
Stem cell therapies offer hope to millions of people with serious illnesses ? and quite
rightly so. One day, the therapy should be able to heal hearts damaged by heart
attack and cure cancer or diabetes. Stem cells, which can divide quickly and develop
into different types of cells, can be extracted and injected into parts of the body which
are diseased. There they can help to re-build new tissue as they do naturally during
the wound healing process.

-------------------------------------------------------------------------------------------------------
Researchers are concerned about the reputation of the new technology
--------------------------------------------------------------------------------------------------------
However, research into how the cells should be extracted and processed so that they
can develop their healing potential is only just now being conducted by scientists. In
strictly monitored, clinical studies on humans, researchers want to find out which
diseases can be cured by stem cells ? along with how the risks can be avoided.
Experts agree that even if they can create a stem cell therapy ?magic wand?, it will still
be years before the technology is available on a large scale.
Nevertheless, doctors and companies all over the world are trying to capitalize on
people?s hope for innovative therapies. They lure paraplegic patients, or those
suffering from heart disease or Alzheimer?s with medical cures which are still largely
unsubstantiated. They are not only jeopardizing human life, ?They are ruining the
reputation of one of the most important innovations in medicine?, says Wolfgang-
Michael Franz, a stem cell researcher from Munich.
Not every case ends as badly as that of the boy from Duesseldorf. Some XCell
patients actually consider themselves healed. Since autumn, the German
Neurological Society (Deutsche Gesellschaft f?r Neurologie or DGN) and the German
Parkinson?s Society (Deutsche Parkinson-Gesellschaft) have gone on the offensive
and issued warnings about the procedures which can cost from ?7,545 to ?26,000,
but are not covered by health insurance. ?Based on the current state of knowledge,
treating Parkinson?s patients with adult stem cells offers no benefit whatsoever?, says
Wolfgang Oertel, a DGN board member. Leading stem cell researchers have said
that ?Up until now there has been no scientific evidence that unprocessed bone
marrow stem cells will develop into nerve cells?. XCell creates this hope.
SCIENTISTS ARE ALARMED
Renowned researchers are no longer willing to just stand by and do nothing about
the situation. In the surrounding region of the two XCell sites of Cologne and
Duesseldorf, in particular, thirteen professors from the Stem Cell Network NRW
(Xcell sites in the city of Cologne and D?sseldorf fall within their catchment area)
have sounded the alarm. They are concerned that: ?XCell is offering stem cell-based
treatments commercially, for which there is no scientifically based evidence of
effectiveness?.
---------------------------------------------------------------------------------------------------------------
wiwo.de: For further information on this issue (in German) see: wiwo.de/stammzellen
----------------------------------------------------------------------------------------------------------------
The regional government of Duesseldorf also has the company ?on their radar?, says
Stefan Fiebig an instructor (Fachreferent) in this area. And this week, representatives
from the Stem Cell Network will be meeting with the local, regional and national
regulatory bodies ? the Paul Ehrlich Institute (PEI). Together with Klaus Cichutek, the
Head of PEI, they want to clarify to what extent patients should be protected against
these types of therapies.
What bothers the researchers is the fact that neither Cornelis Kleinbloesem, the
Dutch founder of XCell, nor any of the doctors working for Xcell, have attracted any
attention to date with publications on stem cells. ?We don?t know these people in the
way we know other stem cell researchers from conferences, for example, where you
can discuss developments or regulatory issues?, said Peter Wernet, a stem cell
researcher from Duesseldorf. In plain terms, hardly any outsiders know how work is
being carried out at XCell.
MIRACLE HEALERS FROM CHINA
This is the kind of thing you would expect from the more than 100 miracle healers in
China, India or Russia, to whom terminally ill patients have regularly pilgrimaged in
recent years. The late artist Joerg Immendorff was among those making such a
journey, travelling to China in 2004 to find a stem cell-based cure for his terminal
amyotrophic lateral sclerosis (a neurological disease), without success.
XCell has established itself in Cologne and Duesseldorf and is attracting similar
attention. That these cities are in the middle of Germany, a country which is
considered the world over to be especially strict when it comes to monitoring and
approving new technologies and therapies, is significant.
Xcell is playing the Germany card for all it?s worth. Emblazoned on the company?s
website is the blue and white badge of the world-famous German technical inspection
agency ? T?V. XCell has achieved their ISO 9001 certification. However, this does
not tell you anything about the quality of the therapy itself. It merely indicates that the
employees have attended training on how to operate the medical machines correctly.
But who will actually make this distinction?
Many of XCell?s clients come from foreign countries. When you enter the XCell
premises in Duesseldorf, which extend over one-and-a-half floors of the hospital, you
see people in wheelchairs, on crutches and you hear languages such as Russian,
Arabic ? and Dutch. An advisor proudly recounts that the company employs over 100
people worldwide. However, the treatments are carried out in Germany. They have
been ?certified and regulated in accordance with German law?, because that way, she
says, ?the patients feel at ease?.
For XCell, feeling at ease is of paramount importance. Dark, oiled, parquet flooring,
white corner seating units, pink tulips on a white table and a bright orange children?s
play area are a pleasant relief from the ?seventies? style of the other floors of the
Duesseldorf hospital.
XCell staff do almost anything in order to ensure that patients have a good and
secure feeling. Even if it means straying away from the facts. For instance: ?Are you
licensed??, asked a prospective patient from England in an e-mail which the
WirtschaftsWoche came across. The advisor answered in the affirmative. The
German government took ?a very close look at the safety aspects of the treatment?
before issuing them with a licence. However, the PEI only played a part in issuing a
permit for the extraction of stem cells, said Cichutek, the Head of PEI. The treatment
itself is currently not licensed.

-----------------------------------------------------------------------------------------------------------------
Pseudo-safety in a legal grey area
-----------------------------------------------------------------------------------------------------------------
In fact, approval for these therapies could not have been given since they have only
recently been legally regulated. Only in the future will new therapies have to be
approved centrally by the European Medicines Agency (EMEA). To date, such
therapies have been legal even without special approval. However, in order not to
torpedo all the promising applications of stem cell therapies and tissue culture
already on the market, the law is granting companies a transitional period (until 2012)
so that they can apply for approval. For special cases, a requirement to seek
approval from the Paul Ehrlich Institute by the end of 2010 has been introduced. This
could apply to XCell.
Gustav Steinhoff, a stem cell researcher from Rostock, is working on getting
regulatory approval. He tests therapies like the ones XCell is currently selling as
being safe and established. He, too, injects so-called adult stem cells which have
been extracted from patients? bone marrow. They are supposed to restore muscle
tissue in patients who have suffered heart attacks. Steinhoff wants to provide
evidence for the effectiveness of the stem cells. In 2009 he began a clinical study
with 150 patients who, by way of random distribution, are treated with or without stem
cells. He is going to apply to the EMEA for approval of the therapy on the basis of the
phase III study, although it will be a huge effort. Yet, the researcher is confident: ?This
is the only way to create a successful product which can be marketed globally.?
THE RISKS HAVE BEEN PLAYED DOWN
For precisely this reason, scientists like Steinhoff are annoyed with companies like
XCell. Not because their ideas are fundamentally wrong, but because it is far too
early to hold out the prospect of cures for serious, incurable, diseases such as
Parkinson?s, multiple sclerosis or paralysis, say the stem cell researchers with
academic backgrounds.
At the same time, XCell plays down the risks on its company website, such as the
risk of developing cancer. In clinical studies, like the one being carried out by
Steinhoff, stem cells, which divide quickly and can develop into different types of
cells, are monitored to see whether they can turn into tumour cells in the human
body. Although this risk is lower for adult stem cells from bone marrow than for those
from embryos, it cannot be ruled out say the experts. There has been at least one
case, which occurred in an Israeli hospital and has been documented in a specialist
journal, in which a 13 year-old boy developed a brain tumor after such a stem cell
transplantation.
In order to clarify what the opportunities and risks associated with XCell?s methods
are, Cichutek, the Head of PEI, would like to see controlled clinical studies of the
therapy. The company has indicated that it would like to begin clinical studies soon
on spinal cord injuries and brain damage. It is virtually impossible to judge the
seriousness of the intentions of the company?s leaders. XCell?s spokesman,
Kempfen, said ?The application to conduct the studies has been submitted, we are
just waiting for the definitive ?go? from the authorities.? PEI is not permitted to either
confirm or deny this.
Up until now, XCell has apparently not followed up even once to see if the therapy
has taken effect. If someone calls up and says that he or she is feeling better this is
included in the statistics, which, for example, show a 70% success rate in curing
brain damage in children. However, although the company promises a
comprehensive follow-up service, has not asked the patients for feedback, according
to those involved. XCell does not want to comment on this or on any other criticisms.

-----------------------------------------------------------------------------------------------------------------
Stem cell therapy can trigger cancer
UNSUCCESSFUL APPLICATIONS
Those who are familiar with the company?s history would, in any case, find it difficult
to believe that Kleinbloesem, the Head of XCell, really wants to conduct expensive
clinical studies with a team which is not well-known for its stem cell research ? or that
he would even be able to. According to research carried out by German radio
(Deutschlandfunk) he has already failed to get approval for corresponding
applications in Belgium and the Netherlands. The background: in his home country,
the Dutchman had already founded a company called Cells4Health. Its business
model was very similar to that of XCell. In the Netherlands, too, serious researchers
and doctors were up in arms. The government reacted and in 2006 it passed a law
restricting this type of stem cell therapy to academic facilities only.
Thus, Kleinbloesem could not carry on ? and he founded XCell in Germany, first in
Cologne and then in Duesseldorf. Now, he is building a further annex just a few
minutes walk from the hospital in Heerdt, which will be used for the purpose of
research and development of the therapy, according to XCell. Tests will finally be
carried out there, after thousands of patients have already been treated
commercially, to try to demonstrate the effectiveness of the therapies.
Scientists would usually do it the other way around.
susanne.kutter@wiwo.de, sebastian matthes
? Handelsblatt GmbH. Alle Rechte vorbehalten
This translation has been conducted by the Stem Cell Network NRW based on the
Article ?Gesch?ft Hoffnung?, Wirtschaftswoche, 19.4.2010.

[michaelsdad00]

This Friday night we will be speaking with a Physical therapist in a nearby state, Georgia, who's client has just returned from Duseldorf, Germany after receiving stem cells from XCell. I look forward to speaking with her and hopefully with them soon afterwards.
Dave

[barbara]

If the patient just returned, what do you hope to get from the conversation? It sounds to me like X-Cell does a good job keeping their image polished for patients and potential patients. It's the treatments that come into question and the secretiveness that they appear to operate in that the scientific community and others are questioning.
You might ask if the patient was given a follow up schedule where the doctor (s) will be checking regularly to monitor the person's progress.

[michaelsdad00]

Barbara,
I acknowledge your suggestions as to what I should question them on. I don't believe that I will subject them to the inquisition that you subject me to, however I will ask them what was done and how they are doing, how was the trip, etc which is what matters to me and possibly to others on this forum. Thank you for keeping this thread alive and to Kristin who spoke up regarding her objection to your thoughts of shutting this thread down.
Dave Snow

[Jeannine]

I have a question for you Michael's Dad:

Where can I locate patients who have been to x-cell? I may be heading to Cologne Germany in April and would be interested in reading about it.

Also, is there any particular reason you're so gung ho on X-Cell as opposed to other clinics?

[barbara]

I think this thread needs to go beyond the niceties of how the trip was, how do you feel, etc. and that is why I would like ONE person, just ONE that can actually provide any clinical evidence that any treatment given at X-Cell has helped them in any manner that would be worth the price they paid.

Dave - You are free to go to any clinic you like, as are others, but the purpose of this forum is to provide information that will help patients not get burned. I am not alone in my criticism of X-Cell, believe me. If you think I am subjecting you to an inquisition, I am not meaning to. It is just surprising to see someone that I thought was very bright and knowledgeable suddenly start to make posts that give reasons such as better vacationing exists in Germany as a reason to get treatment at X-Cell. You need to understand that many on this forum have never had therapy. They are in the initial phase of believing what they want to believe, not what is scientifically acknowledged. They may not understand that a press release is not clinical evidence.

X-Cell does not cooperate in any way with this forum (makes me suspect for sure), with the scientific community in Germany or anywhere in the world or with ICMS or the ISSCR. Are all of these groups mistaken? X-Cell owes it to their patients who have funded them royally, to start doing clinical studies. It sounds like they are going to be forced to do that soon or get out of business which is fine with me.

[michaelsdad00]

Vacationing has very little to do with it. You mentioned that I was basing my decision on the quality of the vacation, not me. I don't find it productive to get into these back and forth postings. There are certain religious sites my wife wishes to see in France while over there however. Safety, including clinic location and of the medical team, quality of accomodations, price of the SCT, etc. all play a factor. I will be traveling with my two teenage daughters as well and don't wish to attract undo attention to us as it is in a third world country. I am sorry if I have disappointed you and that you no longer consider me "very bright and knowledgeable". Your caustic behaviour may have driven others away but I don't care what you think of me. Thank you for acknowledging that we are free to go to any clinic we like even if they do not provide sponsorship your forum.

[dschroed]

Jeannine - I will contact the 2 women I spoke to who took their children to X-cell to see if I can give you their name to contact them. Both are planning return trips.

I do have to agree that the thought of a trip to a third world country with questionable governments is not an optimal situation. I have read too many stories of people coming home from treatments in these countries and getting sick with other ailments like flu symptoms, meningitis, etc.

Barbara - is it possible that X-cell doesn't share some information due to patient privacy rights?

[barbara]

Dave - I don't care if someone is a sponsor of this forum or not as far as saying what I feel, so your criticism is not a fair one. You seem to not understand the purpose of this forum and that is to bring information to people who may have questions about the reliability and safety of a given clinic. You somehow seem to think that not only I know nothing, but the scientific community, ISSCR, ICMS and the German authorities know nothing. I guess you are privy to information about X-Cell that the rest of us aren't.
I will not have you tooting their horn on this forum. I believe that is what your intentions are. I have no idea why, when there is not one shred of clinical evidence that their treatments are safe or effective. I got a similar treatment from Dr. Steenblock for $1500.00 in a private study. I don't think his price is more than a few thousand for this type of treatment without a study and you don't even have to leave the U.S.
I could play your game and say that your behavior will be the cause of closing this thread, but I won't. This forum is one of the few around that really lets people speak their minds without censoring or monitoring. Show me any evidence of clinical efficacy Dave and I will be on your side. Please post the safety studies for X-Cell as well and one last thing, tell us why they are not open to the scientific community and even a simple inquiry from the ICMS or this forum?

[michaelsdad00]

Really??? I just said that I am planning on going there for SCT next summer. I am not playing a game, especially with you.

[dschroed]

Where do these sites post clinic information? I could not find anything, positive or negative, about any clinic. The EMA doesn't post warnings against X-cell, either but I am not sure if they would.

[barbara]

dschroed - You can contact both ICMS and the ISSCR for information from them on X-Cell but they probably don't have much and that is what the problem is. If you go to the ICMS offshore clinical guide on the ICMS site, you will see that X-Cell has provided them with no information. This is a negative. It has nothing to do with patient privacy as these groups are not at all interested in individuals. They are interested in getting a response however and X-Cell has not responded to the ICMS. If I were one to bet, I'll bet that ISSCR has probably fared no better.
Did you see what I posted yesterday? http://www.stemcellpioneers.com/showpost.php?p=11773&postcount=50

Here is a link to the ICMS site and their guidelines.
http://www.cellmedicinesociety.org/

The ISSCR asks you to send them a request for an evaluation of a clinic and then they respond to you after they investigate.

[Kaci's Mom]

Hi,
I'm not trying to get into this "argument", but I really think this is all just a BIG misunderstanding! The reality is Dave and I are both just sitting in the same boat right now. Both of us have young children with CP. And (I know for me anyway) thanks to this forum with it's abundance of invaluable information, it is apparent autologous stem cells seem to be a very credible source. With that said, having a young child with CP and searching for a clinic that will treat a "young child" with their own bone marrow, is no easy task. You have to leave the country, there's no other choice. I have been, like Dave, just looking for information. I just can't recall ever seeing any clinical information on ANY stem cell website offering treatments. Actually the only real clinical information I have obtained concerning Cerebral Palsy is through Google searches for Drs. Ramirez, Steenblock, and Payne (Thank you guys for that!). X-Cell just happens to be one of few clinics that treats children for CP. And the reality is, (I'm pretty sure anyway) this the ONLY stem cell forum that has ANY information about X-Cell that's even close to current! I rely a lot on of information I get from here. And appreciate reading the good and the bad when it comes to "what's out there".

Anyway, as I said in the beginning, what started out as a search for answers seems to have turned in to a big misunderstanding. I personally can say I am less than likely to purse treatment for Kaci at X-Cell because of what I've learned from here. However, that doesn't mean I'm not open to finding out all I can.
Thanks.
Kristin

[alex]

I have been following this thread and I do have a question.

There is a lot of talk regarding scientific evidence and studies regarding stem cell treatments.

I know of one study (I think it was a study) performed by Dr. Ramirez in concert with Dr. Steenblock, regarding children with CP.

Which clinics or doctors, performing stem cell treatments, are providing scientific evidence or studies?

[barbara]

With over 200 stem cell clinics worldwide, I can't provide an answer for most of them. This is something patients should ask however when they research treatment facilities. I am not advocating that small clinics and doctors should be expected to do full blown FDA approved clinical trials costing millions of dollars, but if they are going to track patients as X-Cell claims they have done and then do a study as X-Cell claims to have done, then this should be published, preferably in a peer reviewed publication. Otherwise, anyone could write anything they wanted to and post it on the internet. X-Cell is large enough to be doing published work and shouldn't think they can fool people by simply putting their "study" in a pdf and having it available on site, but that's what they are doing.

Dr. Centeno is an excellent example of someone who is concerned with patient safety. Here is a link to some of his papers (note that he does have one on safety). http://www.centenoschultz.com/Educational_Links_YVMO.html

Dr. Javier Lopez of Regenerative Medicine Institute is currently doing cardiac trials in conjunction with BioHeart. Kristin from BioHeart has promised to post the results that Dr. Lopez has so far as soon as she returns from a trip so watch for that. Dr. Lopez is also conducting clinical trials for COPD and two different eye diseases. His work is conducted under the Mexican Ministry of Health regulations.

I think it is impossible to not track patients and claim efficacy of anything more than an anecdotal nature otherwise.

Dr. Riordan and Tom Ichim (CellMedicine) publish a lot of articles. Many of them are posted on this forum. http://tiny.cc/0b847

Dr. James Braly has written numerous books and published articles. He works with Dr. Ramirez and is our host this month for the Ask the Doctor forum.

Dr. Grossman has published several papers, has co-authored several books and is pursuing clinical trials for IPF and COPD in the near future.

Beike recently published a paper on safety. The information was posted on this forum several weeks ago. http://www.beikebiotech.com/index.php?option=com_content&view=article&id=433&Itemid=100012

ICMS offers all companies an opportunity to use their Patient Registry. ICMS does the work of the follow up. How hard is that? I inquired about X-Cell and was told that ICMS has made numerous attempts at trying to contact them. They have been non responsive.

Look through the Ask the Doctor threads. I always ask for bios from the hosts. You can also Google information on doctors and clinics very easily and get a lot of information that way as well.


Here is some good insight from Dr. Centeno on research. I just received this today from him.


Dear all,

As you know, we are a research based practice, meaning that we publish more research than any other non-university based pain practice in Colorado. I just spent a few hours indexing our National Library of Medicine citations for our web-site and I thought you might be interested, see http://www.centenoschultz.com/Educational_Links_YVMO.html. These are our 24 indexed articles only, there about another 10 that aren't indexed and thus aren't on this list.

Research is a sort of a thankless endeavor as a private practitioner. A simple editorial may take a few hours to up to 10 hours to polish. A full blown research paper involving hundreds of subjects (we have two more of those just submitted for publication so not listed here) can literally take 100 hours or more to compile, write, polish, and re-polish, then another 5-20 hours to rewrite parts for picky peer reviewers. If you're in academia, it's publish or perish, so there are significant benefits to taking the time to publish your work like promotions and grants, etc... In private practice, you do this because it simply needs to be done.

Christopher J. Centeno, M.D.

This speaks volumes to me. For some, it's not all about the money. A nice balance can be achieved in my opinion. Patients can thank doctors like Dr. Centeno and the others that publish for legitimizing stem cell therapy. They are truly Pioneers and have my utmost respect.

[alex]

Thanks for that info, Barb

[barbara]

Thanks Alex.

I also forgot to mention that Jeannine and I with a consultant that we recruited, administered the Stem Cell Advance (now Stemtrition) Treatment Protocol for over two years. We liked the product, but had to prove efficacy. The consultant in collaboration with Dr. Young will now be using the information to incorporate the product into another study that they hope to be able to get funding for in the near future.
If Jeannine and I can put together a protocol (keeping in mind that we do have serious health concerns and limited resources), then what really is X-Cell's excuse? It could be fear of exposure I guess or it could be that the money is so good, they think why take a few moments out to do some studies? I really don't know why, but those reasons come to mind.

[dlbelbin]

Wow! Wow! Wow!
I have so much to say but will not. When I first started posting about Xcell, it was out of frustration. Could I now be considered a paid recruiter for posting our experiences? Why should we post only to be met with argument? Is this not an open forum? Why the argument against Xcell and the support of other ?specific? clinics? This is one of the reasons for not posting. I apologize to those that seek continued information on my family?s progress either good or bad.

This is about ASCT and the hopes of improving the quality of life for us or loved ones. Not of arguing and pointing fingers to clinics or to individuals. I do thank the argument; it did help in my research of clinics and assisted with my decision.

The ?proving? of personal success or failure has got to stop. The successes of folks treated from the Xcell center is only met with distrust, suggested as paid recruiters, or other. It does not matter what clinic, but I think all walk of life?s adventures should be more positively received, good or bad.

When it comes to money, well, I guess it?s time to go.

All things going well with my family.

David

[barbara]

If this weren't an open forum, this thread would have been removed. This forum was started to provide support for patients as well as to discuss stem cell therapies. I asked for anyone to respond to me about X-Cell and I received many responses ranging from a government run stem cell resource center to a group of doctors who oppose what is going on at X-Cell. I posted some of what I received, but not all of it as some was sent in confidence. I did not receive any positive responses from the professional stem cell community. X-Cell could put this matter to rest by getting on with their promised research studies and publishing results. Since, their sales rep does read this forum, I would suggest he urge the CEO to get on with them. I am sorry you do not feel this is needed.
I know you have been busy and weren't posting on your blog either for awhile, so it is good to know you are doing well.
I did not red flag X-Cell, but they certainly do not fall into the same category as other clinics who are making real efforts to move stem cell therapy forward and who are cooperative and helpful on this forum. I feel I have explained my position many times, so you have to understand my frustration as well when no one seems to find any importance in studies, follow up, cooperation, ICMS membership and favorable reports from those in the know. These are all lacking with X-Cell. If you feel you got your money's worth, than for you that is all that is needed. I have an obligation to make it clear to other readers that your experience from all the information I have received and gathered, is probably unique.

[barbara]

http://www.stemcellpioneers.com/showthread.php?t=3858

[dschroed]

This is sad. I will need to investigate this before I go. I just wish we could have options in safe countries.

[pink7]

It is worrying that Doctors are doing these procedures on children in Germany.It is really sad for the family of the little boy.

[dschroed]

I did look into this. It was not a stem cell procedure that caused this. I do not know too much about the procedure that was being performed when this happened. The doctor is no longer there and is being prosecuted but the clinic was cleared, apparently. It is very sad and very unfortunate, no matter what was done.

[barbara]

Can you provide us with the information to verify this? It would be appreciated.
What about the 10 year old boy who almost died? Do you have information on that as well?

[barbara]

Here is what X-Cell says on its site:

For Our Patients - Official Response to Recent Events
October 26, 2010

Dear prospective patients,

It is our mission to provide you with the most promising autologous stem cell treatments in a safe, ethical and professional manner. We therefore believe that it is our duty to inform you publicly about recent events that have been the target of biased, erroneous and even undercover reporting methods in the news media in order to defame us.

Over the past few months, two young children with most severe forms of cerebral palsy suffered serious complications during their neuro-endoscopy procedures; one resulting in a very unfortunate death which everyone at the XCell-Center deeply regrets. However, one must realize that all medical procedures are associated with limitations and risks; especially in situations with severely disabled patients.

Brain surgery is a serious medical intervention with much higher risks than less invasive procedures. The more invasive, the higher the risk, and in many cases, the higher the potential benefit. This balance must be judged in each individual patient, especially in the cases of children, by the treating doctor in close collaboration with their parents. Unfortunately, one of our neurosurgeons has, in our opinion, failed to correctly assess the risk-benefit-ratio in a few patients. Consequently, after the first complication, the surgeon was issued a warning. After the second complication, the employment contract of this particular neurosurgeon was terminated. These complications occurred due to the surgery itself. Consequently, these events are unrelated to the stem cells. The events were reported to the health authorities by XCell-Center.

When severe medical complications occur, it is a routine procedure to investigate. The public prosecutor, Christoph Kumpa confirmed in a statement that, "The inquiry is directed towards this specific doctor and her actions and not XCell-Center."

So far, more than 100 brain surgeries have been performed at the XCell-Center with about 2 percent complication rate. This complication rate is on the very low side by international comparison. Overall, XCell-Center surgeons do an excellent job. However, whenever 100 brain surgeries are performed within the span of 12 months there will be some level of complications. Because of this potential risk, all neurosurgical patients receive personal counseling from the operating neurosurgeon during which time they are informed of possible complications. After that, they all sign a comprehensive, written informed consent document.

Due to the above clarified complications, brain surgeries as well as lumbar punctures and other spinal procedures were temporarily put on hold. However, this moratorium for lumbar punctures and spinal procedures was lifted within a week. Safety reports of 1500 lumbar punctures and at least 400 in children exist. To date, no patient has reported a serious complication. Apart from the typical symptoms of lumbar puncture such as headache, vomiting, backache which are transient albeit intense, there are no other adverse reactions. So far the facts clearly demonstrate that lumbar puncture is a very safe method of application. Many patients, including children, have considerably improved after receiving this treatment. Every week the XCell-Center receives emails from parents expressing their thanks and happiness with the results. Video and written documentation of many patients' improvements are published on the XCell-Center web site and Facebook page. There are many others catalogued in our patient files.

With regards to the sensationalized stories currently published in the news media, journalists crave miracles or scandal because anything in between simply doesn't sell. Unfortunately, because the XCell-Center isn't offering miracles, we are wrongly accused of perpetuating scandal while the real story, that many patients experience numerous levels of improvement after treatment, remains largely untold.

Several academic institutions suggest that XCell-Center harms stem cell research, however they consistently fail to point out that the XCell-Center is the only stem cell institute producing cell products under governmental GMP approval and that it is authorized by the competent governmental authorities to collect, process and release stem cell products while at the same time, administering such stem cell products in a controlled setting. This includes a clear indication setting, clearly defined inclusion and exclusion criteria, and status measurements of the patient via radiological scans, laboratory testing and cognitive and physical determinations as well as video documentation for each individual patient. Moreover, the Xcell-Center is actually conducting a preclinical and clinical research program at the level that is required by the EMA (European Medicines Agency) and the US FDA. Worldwide, the first placebo controlled clinical study in patients with spinal cord injury has commenced. We intend to file in the near future for obtaining marketing authorization for several neurological indications and other life threatening conditions. After approval, the stem cell treatment will be made commonly available throughout the EU and US.



By Robert Mendick and Alasdair Palmer
Published: 23 Oct 2010
This is from the Sunday Telegraph, the last paragraph being the most perplexing in my opinion:

Baby death scandal at German stem cell clinic


The XCell-Center


Europe's largest stem cell clinic which treats hundreds of British patients a year is at the centre of a scandal following the death of an 18-month-old baby who was given a controversial injection in the brain, it can be revealed.


A doctor who worked at the clinic is now under criminal investigation over the child's death in August and the serious injury caused to a second child in another alleged botched operation three months earlier.
The clinic has been accused of bungling the operations and failing to respond quickly enough when the surgery went wrong.


The XCell-Center, based in D?sseldorf, has attracted thousands of patients with incurable illnesses from all over the world.


The clinic claims its technique for stem cell transplantation has had success in treating 17 different diseases including cerebral palsy, multiple sclerosis, autism, Parkinson's, Alzheimer's, heart disease, diabetes and spinal cord injuries.


Such stem cell treatments, which typically cost between ?10,000 and ?20,000, are banned in the UK and most other European countries unless as part of a clinical trial because there is still no scientific proof that they work.


A Sunday Telegraph undercover reporter who suffers from multiple sclerosis and is confined to a wheelchair was told last week during a consultation at the XCell-Center that he could walk again.


According to XCell, about 25 British patients a month ? including children with severe disabilities ? are treated at its clinic in D?sseldorf and at another in nearby Cologne.


The treatment involves taking bone marrow from patients, harvesting stem cells from the bone marrow and then reinjecting those stem cells into other parts of the body, including the brain, the spine and the neck.


But XCell is now under scrutiny following the death of a child in August, The Sunday Telegraph can reveal.


The 18-month-old boy, whose Romanian parents lived in Italy, was injected in the brain with stem cells and subsequently died.


In May a 10-year-old boy from Azerbaijan almost died when the same procedure went wrong. His family is suing the clinic.


Criminal prosecutors are investigating the death and the case of the other child, who is now understood to be more severely disabled than when first treated at the clinic.


Dr Michael Sabel, chief neurosurgical consultant at the University Hospital D?sseldorf, has accused XCell of failing to react quickly enough when the 10-year-old boy began to suffer internal bleeding in the brain.


The child was brought to his hospital where he underwent life-saving emergency surgery.


Dr Sabel then wrote a letter to authorities warning them a child could die if the procedure was repeated at the clinic.


Three months later the Romanian boy died after being rushed to a hospital, about a 15-mile drive from D?sseldorf. Dr Sabel is mystified why the child wasn't brought to his hospital five minutes away.


Dr Sabel told The Sunday Telegraph: "What we had was an unjustified surgical procedure with complications which was then not properly dealt with. They had injected the stem cell into the brainstem, which is the most delicate
structure in the brain."


Dr Uta-Kristein Tamaschke, the doctor who injected the children and who had pioneered the stem cell transplant into the brain, is no longer working at the XCell-Center.


Christoph Kumpa, the public prosecutor in the case, said: "The inquiry as far as I am concerned is directed towards this specific doctor and her actions and not the firm.


"We are dealing with a mountain of medical paperwork at the moment. Should it come to legal proceedings, they will not take place before the summer of next year at the earliest." He said XCell was co-operating with his office.


The Paul-Ehrlich Institute, which regulates medicines in Germany, produced a report following the death which concluded that XCell's procedure for injecting stem cells into the brain had been conducted with "damaging consequences".


It said the treatment was "precarious" and that under German law such "precarious" treatments are illegal and should stop.


The XCell-Center was sent a list of questions by The Sunday Telegraph to respond to last week. In an email sent on Thursday, the clinic promised to answer but had failed to do so by the time of going to press October 22.





From the Stem Cell Network Blog

OCTOBER 22, 2010

Questions raised about XCell Center
In recent years the Stem Cell Network has worked closely with its international colleagues to shed light on clinics offering ?stem cell? therapies for which there is scant scientific evidence. One such initiative is A Closer Look at Stem Cell Treatments, a web resource created by the International Society for Stem Cell Research, and a useful reference for those considering treatment options outside of Canada.

One assumption often made is that such rogue clinics operate primarily out of exotic locations such as China, Thailand, or closer to home, Mexico. However, reprinted here is a story that appeared a few days ago in WirtschaftsWoche (a leading German weekly business news magazine) about XCell Center, a private company based in D?sseldorf, Germany and one of the leading advertisers of stem-cell based therapies on the web.

Death forces authorities to place restrictions on the D?sseldorf company XCell

by Susanne Kutter, October 16, 2010

Cornelis Kleinbloesem is a shrewd entrepreneur. For almost a year now, patients with incurable diseases, and parents with mentally and physically handicapped children have been travelling from all over the world to receive treatment at his XCell Center in D?sseldorf. There, they hope for a cure for themselves or their children from the stem cell therapy that he and his team of doctors offer ? at a cost of up to 18,500 Euro. Serious stem cell researchers have just begun carrying out studies to test the effectiveness of such treatments, and now consider the belief that the XCell treatment can succeed to be utopian.

Kleinbloesem?s claims of success could now be his downfall. Some of the 3,500 treatments he asserts have been carried out have gone terribly wrong. Stem cells were injected into the brain of an 18-month-old boy, who hours later collapsed and died in the children?s neurosurgery ward of the Helios Clinic in Krefeld. ?The medical records have been confiscated,? verified D?sseldorf District Attorney Christoph Kumpa. A doctor at XCell had previously injected stem cells into the brain of a 10-year-old boy from Azerbaijan last Easter, causing cranial bleeding that almost killed him. The family is currently filing suit with the D?sseldorf District Attorney?s Office (WirtschaftsWoche 16 and 32/2010). Three further near-catastrophes are also known to have come to the attention of WirtschaftsWoche.

Kleinbloesem and his dubious stem cell therapies fall into a legal gray area, and will continue to do so until at least the end of this year. Since this death, however, even authorities who previously saw no possibility for intervention have become active.

The Paul Ehrlich Institute in Langen, the organization responsible for stem cell issues nationwide, has drawn up an experts? report that categorizes the use of stem cells, at least in the brain, as questionable and therefore forbidden. Excerpts have been made available to WirtschaftsWoche: ?According to current scientific understanding, the XCell Center?s stipulated use of stem cell treatments has damaging effects that far exceed any tenable limits within medical science.?

The state authorities have set a deadline for the company to react to these allegations ? the first step on the way to prohibiting the therapy. The Dominikus Hospital in D?sseldorf-Heerdt (two floors of which have been leased out to XCell for a period of ten years) is also distancing itself from the company: ?XCell wanted to work more closely with us in children?s anaesthesia and intensive care, but we refused,? said Hospital Manager Verena H?lken.

XCell did not respond to questions posed by WirtschaftsWoche, but Kleinbloesem did react. He fired the doctor who had operated on the children and announced to authorities that his clinic will no longer perform treatments on the brain. In fact, a few days ago his employees sent a family from Spain back home again, explaining to them that, ?The German government has forbidden this treatment.?



It sounds like X-Cell is under the gun after what has happened.



Stem cell law loopholes allow XCell-Center to operate in Germany
The XCell-Center, which would be banned in the UK, has been able to thrive in Germany due to a legal loophole about to be closed under new European legislation.

By Robert Mendick, Chief Reporter, Telegraph
24 Oct 2010

Stem cells have promised to provide a revolution in healthcare.
The law governing stem cell clinics is extremely complex.
The UK classifies stem cell treatments as medicines. This means that before procedures can be licensed, the therapies must undergo the same kind of rigorous trials as those used for other medicines.

The time it takes to prove scientifically that the treatment both works and is safe has allowed clinics like XCell to spring up abroad attracting foreign patients in large numbers. Such treatments are also currently unavailable in the US and in many other countries in Europe.
But how much longer XCell will be allowed to operate in Germany is not clear.
A European Union regulation passed in 2007 now defines stem cell transplantation as a medicine and Germany has come into line with that. Under the regulation, XCell has until 2012 to show its treatments are effective and safe.

[barbara]

It could be an uphill battle for X-Cell to prove efficacy for all the conditions they treat. This man is no different from the rest of us looking for something that can help him. I thought his story was well told.



The XCell-Centre holds out hope of a treatment for incurable diseases. Alasdair Palmer, who has MS, travelled to D?sseldorf for a consultation.


By Alasdair Palmer
22 Jun 2010


Link to video http://www.telegraph.co.uk/news/newsvideo/8082001/Hope-of-a-cure-at-Europes-largest-stem-cell-clinic.html
Hope is important to everyone, but it is particularly precious to those who suffer from an incurable disease. I am one of that group. I was diagnosed with multiple sclerosis nearly 20 years ago.
I now have to use a wheelchair, and the future is not particularly rosy. So whenever I hear that there has been a new scientific development which could turn out to be a cure, or which could at least halt the progression of the disease, I start to hope.


I know that, on every occasion in the past, the news of a cure has turned out to be false: the claims that the new treatment can reverse MS have, on closer inspection, all turned out to be bogus.
But I can't stop myself from hoping that this time it's different: this time the elixir really has been found.
Like everyone else with a neurological disease, my hopes have been, and are, raised by stem cell research.
In theory, there is every chance that eventually, stem cells ? the cells which have the potential to convert themselves into any kind of specialist cell in the body, from brain and nerve cells to the cells that make up your skin or your liver ? might eventually provide an effective treatment for MS.
But progress towards that goal is in practice proving to be agonisingly slow, not least because everything that has the potential to do good can also do harm.
It requires a great deal of research to show that a therapy isn't going to be damaging. The history of medicine is littered with treatments that seemed to be miracle cures, but turned out to be harmful.
Even techniques such as heart transplants, which are now routinely practised and save thousands of lives around the world every year, started by killing all the patients who had them.
None the less, when I was asked by the editor of The Sunday Telegraph to investigate a medical centre in D?sseldorf that offers stem cell treatment to those who can afford to pay for it, I was immediately intrigued.
I'm aware that a British doctor has been struck off the medical register in this country for offering such treatments. I've also written sceptical articles about the claims made by doctors who say they can provide stem cell "cures" for MS.
I've also read non-technical summaries of the scientific papers published in medical journals which point to the difficulties with existing stem cell techniques, and to the fact that there is as yet no trial which has provided solid evidence of their benefits.
And yet ? there is always the possibility that a brilliant medical researcher has come up with a very effective technique which, while it has not yet been proved to be effective, actually is.
So in spite of my well-rehearsed scepticism, the XCell-Centre in D?sseldorf got my hopes up. A quick glance at its website demonstrates that its doctors are very confident that their stem cell treatment is effective in treating MS and other neurological diseases.
My hope focused on a single thought: it is surely not impossible that they have found something that works. And if it is not impossible ? mightn't it be worth trying?
I booked myself a consultation with Professor Doctor Haberland. I was immediately informed that it would cost 300 euros, and that I would have to pay before the consultation.
The X-Cell Centre is housed in a large hospital building overlooking the Rhine. As I waited for my appointment, it was clear that everyone else who was waiting for a consultation suffered from the same hope that I did.
Some of them were considerably more desperate for a cure than I am. One woman with advanced Parkinson's Disease ? she had travelled all the way from the United States ? told me quite simply that she knew the treatment wasn't scientifically proven.
She even realised that there was a significant chance it wouldn't work. "But what is my alternative?", she asked plaintively. "For me, there is none, except waiting until I degenerate to the point where I die, or want to die."
Our conversation was interrupted because I was called in to my meeting with Professor Haberland.
He is a genial man with an air of intense professional competence: he is a trained neurosurgeon who has spent most of his career working on injuries to the spinal cord. He was friendly and patient.
He said that his treatment consisted of taking stem cells from the patient's bone marrow, separating them, and then injecting them.
"We have some amazing results with this treatment," he told me.
He insisted that the best results came from combining this approach with an operation developed by an Italian doctor named Zamboni, which involved, Prof Haberland said, widening veins in the patient's neck.
Zamboni had, Prof Haberland claimed, established that many neurological conditions were connected to a narrowing of these veins.
When the operation to widen them was used in conjunction with the injection of stem cells, "you have a win-win situation ? 80 per cent of our patients report improvements".
He pointed to a Dutch patient who had been in a wheelchair prior to the operation, but after it, had been able to walk.
So if I had the treatment, would I be able to walk? "You would have a chance", Prof Haberland replied. "The response is very different from patient to patient. But you would have a chance." And it would only cost about 19,500 euros.
Against my better judgement, I felt my hopes rising. But there were also some questions. How did Prof Haberland know how successful the treatment was? What was the follow up? "We ask patients to fill in a questionnaire three months after the operation, and we see them here and test them after six months", he said.
There is, however, considerable doubt whether a patient questionnaire has any value, since it is not an objective measure.
There is still more doubt as to how many patients actually bother to travel all the way to D?sseldorf for an assessment by the centre six months after the operation.
Moreover, Prof Haberland said he had only been doing the double operation ? the combination of stem cells and widening the veins in the patient's neck ? for six months.
How, I wondered, could there be any reliable data from such a short period? Would Prof Haberland be publishing his results? No, he said: he had no plans to. "We need more cases and then we need to make a double blind study in multi centres. This is a long way off."
But if Prof Haberland hasn't enough patients for a proper trial ? how can he be sure even that his operation isn't harmful, let alone that it actually benefits patients?
He was unequivocal that because he uses stem cells from the patient's own body, injecting those cells can't hurt the patient.
It certainly sounds plausible. But no one can know until there has been a large-scale study.
Professor Neil Scolding of Bristol University followed six patients with MS after they had been injected with stem cells taken from their bone marrow for over a year.
Careful monitoring showed that none of the patients were harmed. But the evidence of benefit was less certain: rather than any improvement, it suggested that the patients' condition had stabilised instead of deteriorating further.
It became increasingly obvious in the course of my discussion with Prof Haberland that he does not have any clear, objective and verifiable evidence that his treatment provides the sort of benefits that he claims for it.
It is not even clear that he and the hospital have followed up their patients at all. I asked for any records showing objective evidence of how patients improved after the operation. None have been provided.
That was not enough to extinguish my hopes altogether, however, for Prof Haberland is very persuasive.
He is a subtle salesman. He held out the possibility that I would experience enormous benefits from his operation ? but he did not promise them outright. That leaves just enough room for hope to do its work of eroding doubt.
I recorded my interview with Prof Haberland, and showed a transcript to Prof Scolding, an internationally-recognised neurologist and expert on stem cell treatments for MS.
Prof Scolding noted that Prof Haberland's claims about what bone marrow stem cells can do are not, in principle, wrong ? but he also pointed out that that is quite different from showing that his treatment can or does make the symptoms of anyone with MS improve.
Prof Scolding was more forthright in his criticism of Prof Haberland's claims for the "vein clearing" operation developed by Zamboni.
"There are potentially serious consequences for stenting for this so-called condition ? one patient has died in the US," Prof Scolding stated.
"There is emerging published evidence that there is no link between venous drainage in the neck and MS.
"Applying this 'treatment' to patients with Parkinson's and other neurological conditions ... is extremely eccentric."
He added: "If patients had genuinely responded to [Prof Haberland's] evidence-free combination of stem cell therapy and vein clearing treatment, it would be scandalous for him not to have published his results.
"To my mind, if they are persuading often-desperate patients to pay large sums of money for treatments that have no sustainable evidence to support them, it is cynically exploitative and a disgrace to the practice of medicine."
That, to me, sums it up perfectly. It extinguished whatever hope Prof Haberland had kindled in me.

[dschroed]

This article is very discouraging for anyone hoping SCT will help them. X-cell is no different than the Mexican clinics promoting treatment. Biogenisis is offering the CCSVI scanning and treatment in conjunction with SCT also, just for more money. All of the clinics say they have promising results, yet none say they cure anything. Fortuately, I do not hold very high regard for the UK Telegraph which reminds me of the US National Enquirer. The CCSVI treatment is being researched worldwide with at least 3 studies recruiting in the US at this time and the National MS society is backing this research.

[barbara]

X-Cell is different than some clinics as they are not doing any clinical studies. RMI, for instance, is involved in several clinicals under the Mexican Ministry of Health. The reason that clinics are not claiming they have a cure is because there is no cure at this time. Any clinic that claims they have a cure had darn well better be prepared to prove it.

It is frustrating and disappointing that advancements in medical treatments seem to take so long, but on the other hand, it is encouraging to now have hope and at least therapies that are stopping the progression of many diseases.

X-Cell really needs to get rolling on the studies they have promised for so long. If they are claiming that 80% of MS patients are helped with their therapy, then they should be backing this up with clinical evidence. This would prove the naysayers wrong and would have patients waiting in line for treatment. Being ill makes us want to believe, but it should not make us disregard common sense.

[bern98]

Hi Barbara
I have noticed that you have had several procedures completed! Did any of these help your condition? If yes..where were they performed and at what cost?

[barbara]

Yes, I have had several stem cell treatments, not all successful, two outright disasters.

Stem cell therapy is not a magic bullet. You need to have reasonable expectations. For instance, if a patient's condition is severe, it is unrealistic to think that a single treatment will completely turn the condition around and that the patient will be completely healed. Beware of companies claiming high success rates and cures. Most are smart enough not to use the word cure, but many, such as X-Cell that was recently shut down, claimed very high rates of patients who had improved after their treatment. This company never backed up its claims with scientific evidence and to me, that was like a huge warning light in my brain telling me that they were merely treating anyone who could pay, no matter what their condition was and that post treatment follow up was not a priority. It's devastating for desperately ill patients to be preyed upon, but it is also reality, so as always, it's Buyer Beware.