New hope on the horizon

[Jane]

I received an Email last night from Osiris with a news release. One of their products (stem cells) that has proven effective and is on fast tract for heart has also shown improvement for lung function. Now they have partnered with another company and has been awarded a DOD contract for $224 million for this product to combat radiation. This is the same stem cell product used in Mexico for COPD. This company is located in Wilmington, DE and COPD is on their list down the line for trials. I think with the increase in recent trials with other companies that we won't have to wait the 10 years predicted to have a rejuvenation product available. There is always something new around the corner. Read the release - http://investor.osiris.com/releases.cfm

[Jeannine]

Jane

Thanks for the update. I have been closely watching this company for the past 6 months. I found their results of improving lung function by 17 points to be quite astounding. Now I wish I had bought shares two months ago when the thought occured to me. :confused:

[danny]

I also got the same email and have been following them. I talked to Alan Trounson from Australia (now the new head for California stem cell center). He thinks this will be the first company in the US to do lung stem cell studies.

Also this company has cells that has shown to create lung tissue.. we should buy some of these and try them!

http://www.bioe.com/Product/Product.aspx?catID=18
look at all the uses for these
http://www.bioe.com/Product/Product.aspx?catID=18&prodNav=lit

Danny

[Jane]

I recieved an Email on this post and it was inadvertently deleted. I don't remember the questions. Please reask.

[barbara]

Danny - I am fascinated by the sites you posted. It does say they are available for research only, however, aren't we all researching in our own little way? Things are starting to shake, rattle and roll Pioneers. This is good news and so is the info about Osiris.

[hlichten]

I don't like to keep mentioning this but...

Clinical trials in the USA are double-blind trials.

Neither you nor the doctor will know if you are actually getting stem cells or if you are getting placebo (water). It will be somewhere between 6 months to 3 years (depending on the length of the study) when the study is unblinded.
Then, anyone receiving placebo will be offered the real stem cells.

50% get placebo in a Phase I and usually a Phase II. In a Phase III a higher percentage get the real cells.

For people who are suffering right now, it is unlikely that you would want to risk being one to receive placebo. I agreed once to be in a heart stent study, and guess what? I got the placebo stent! Lucky me!

Trials are VERY exciting! It means that we are closer and closer to some treatment or treatments being actually FDA approved. Of course, that does not mean that insurance will pay right away for that treatment, but even that is closer and closer.

I just want for anyone considering being in a trial to fully realize that they may not actually receive stem cells when they are first treated.

Osiris and the others are talking about these trials. Treatment will likely be free, but you may get water, and neither you or the doctor treating you will know.

Sorry, but I feel an obligation to stress this to everyone.

[Jane]

Harv, you are absolutely right about clinical trials. My husband was part of a trial at NHI at Bethesda, MD some 10 years ago. The thing that is encouraging for me is that I KNOW some of the pharmaceutical companies have been given Fast Track status with the FDA because of the urgency and that means that the thousands of individuals required to be a part of the study has been drastically reduced and also the cost of the study reduced.

The companies that have targeted heart are doing so because it is the most critical. Side issue from that is the lungs have also benefited which just may move the whole process forward for COPD.

As for insurance companies.... They are going to take the least expensive way out. Blue Cross is already looking at India for hip and knee replacement because it is 80% cheaper there for the same surgery. Too bad my hospital is in the process of doubling it's size with a new surgical tower and I am knocking myself out trying to fund it.

As for my husband and myself, we are going to take another road and I will share that with you personally if/when we start seeing results.

Good luck to you for improved health.
Jane

[barbara]

Jane - What a cliffhanger. Now, you have me really wondering. You seem to be very knowledgeable about clinicals and the fact that you are helping with funding at your local hospital is very commendable. I look forward to your unveiling what you mean and thanks for your informative posts. I think it is clear that hope is getting nearer and nearer for many people. If a person can take the time to wait for clinicals and as Harv pointed out, possibly get no more than water, then what these volunteers do is very worthy of Pioneer status also. For those that would compromise their lives by waiting, they have no choice but to try to find what is best for them at this time and a clinical would be iffy at best in my opinion.

[danny]

Most of orsis phase I trials dont' have placebo...

[barbara]

That is fantastic news Danny. 2008 is getting better already.

[hlichten]

Most of orsis phase I trials dont' have placebo...

How did they accomplish that?
I had understood it to be a requirement of any FDA-sanctioned trial.

[hlichten]

...As for my husband and myself, we are going to take another road and I will share that with you personally if/when we start seeing results...

Great.
I already have trouble sleeping at night, now I really can't sleep until this is divulged! ;)

[danny]

another article !!

http://www.osiristx.com/pdf/PR%2067%2007Jan08%20Osiris%20Regains%20Rights%20fo r%20Cardiovascular%20Indications.pdf

[JC the Fox]

Osiris' web page shows that Provacel was used for the heart attack patients, and, in fact, was done so in a double-blind test. It was this test that also showed the lung function improvement. The DoD contract for Osiris is for Prochymal, which is also the subject of Danny's last link. I read that link, and it says that Prochymal is being tested in clinical trials for the heart.

Do either Danny or Jane know what the difference in the two are? And will a new product be used for lung function tests?

[Jeannine]

I don't know what the differnces are between the different prodycts but here is the chart I found on their site and it appears that Prochymal will also be tested for Lung Disease

http://www.osiris.com/images/pipeline_chart_5-10-07.jpg

I hope this doesn't take forever.

[hlichten]

Osiris' web page shows that Provacel was used for the heart attack patients, and, in fact, was done so in a double-blind test. It was this test that also showed the lung function improvement. The DoD contract for Osiris is for Prochymal, which is also the subject of Danny's last link. I read that link, and it says that Prochymal is being tested in clinical trials for the heart.

Do either Danny or Jane know what the difference in the two are? And will a new product be used for lung function tests?

I read through most of the info on their website, and found it quite confusing.
My biggest "complaint" with their site is that they speak of their products, but don't really say anywhere what the product really is. All that can be ascertained is that these are blood cell products of some kind. What they are, specifically, is either not being divulged or not easily understood. I can understand the former, if there are pending patents, etc.

I am in no way putting them down, I would just really like more specifics on where their cells come from, and what they have done to them.

If I am missing something obvious in reading their information, please enlighten me.

If anyone knows any true specifics about their products, please post here.

[JC the Fox]

I'm hardly qualified to answer, but, from what I've gleaned, Osiris is using mesenchymal stem cells (MSC) taken from the bone marrow of adult donors, then grown in a culture. The cells are "injected" into the patient by means of an IV.

It is my understanding that stem cells can not be patented, but the "delivery system" can be. Which is what prompted my question as to the differences in the products. It also leads to asking the question, "If Prochymal is approved for use with heart problems, is a physician prohibited from prescribing it for those of us with lung problems?"

[danny]

Its all the same type of product... MSC's cells home to where ever damaged tissue is. Lungs / Heart/ Stomach etc.

[hlichten]

...It is my understanding that stem cells can not be patented, but the "delivery system" can be...

From what I understand, the delivery system can or could be, including any chemical additives (i.e. the "cocktail" formula) and any unique laboratory processing post collection.

Its all the same type of product... MSC's cells home to where ever damaged tissue is. Lungs / Heart/ Stomach etc.

So, what if anything is supposed to be unique about Osiris, other than they are pushing forward with trials?

[Jimmarshall]

Is SCB the clinic in Mexico using this product?I received an Email last night from Osiris with a news release. One of their products (stem cells) that has proven effective and is on fast tract for heart has also shown improvement for lung function. Now they have partnered with another company and has been awarded a DOD contract for $224 million for this product to combat radiation. This is the same stem cell product used in Mexico for COPD. This company is located in Wilmington, DE and COPD is on their list down the line for trials. I think with the increase in recent trials with other companies that we won't have to wait the 10 years predicted to have a rejuvenation product available. There is always something new around the corner. Read the release - http://investor.osiris.com/releases.cfm

[Jeannine]

Jim Marshall

I believe the growth factor ingredients are proprietary for Osiris as well as SCB. Osiris uses donated adult stem cells as opposed to SCB which uses cord stem cells.

We've been waiting over 8 months for the lung disease product to be available for clinical trial. I hope the FDA will fast track it. However, it could take years.

[barbara]

It seems we keep hearing this news, but like Jeannine states, nothing has happened at this point in time. It may not be ten years, but for some of us, even a delay of a few years is just not an option. The disease is progressive and for me it had taken a real nasty turn. My FEV1 dropped 5% in one year which had my pulmo real concerned. Also, even if trials are started earlier and treatment as well, it will take more time to get any insurance to cover it, so why wait? I think better results as far as stopping the progression of the disease are achieved the earlier that you get treatment. Just my opinion and that of several stem cell doctors.

One other thing that is worth mentioning. A person needs to consider if they are well enough to go through a clinical trial. Harv recently posted about his experience with this and it wasn't something that a sick could person could easily participate in. I got my treatment in less than 30 minutes and that was it. No months of monitoring and pre testing, no mounds of paperwork, just in and out. I realize that some people wouldn't feel comfortable with this, but I am one that did.