PDA

View Full Version : Installment 73 - Ask the Doctor with Rob Schemitsch/Translational Stem Cell Therapy



Jeannine
08-28-2014, 01:19 PM
About Rob Schemitsch/Translational Stem Cell Therapy Foundation

Rob Schemitsch has spent the last 11 years as an industry leader in the development of CGMP stem cell manufacturing and cryogenic storage facilities, business development and medical marketing. He has been instrumental in launching the Celebration Stem Cell Center which improves the quality and access to these stem cell therapies Rob has extensive experience in adult stem cell / tissue banking programs and launching a contract manufacturing and contract research organization (CRO/CMO). Rob has also served as the Executive Director of the Translational Stem Cell Therapy Foundation. The foundation is committed to increasing public awareness of the healing effects of stem cells. He has been pivotal in developing programs with the Arizona Department of Education to conduct ongoing educational lectures for students and teachers throughout the state.
Contact Translational Stem Cell Therapy Foundation:
602-625-6910 Cell
robschemitsch@yahoo.com

Q & A

Q: Is there any point to someone who has a chronic disease banking their stem cells? It seems to me that getting treatment is more important than banking when one is chronically ill.
A: I would agree that if you are interested in stem cell therapy for a chronic disease, then seeking out a clinical trial in the United States would be the right place to start. Check out www.clinicaltrials.gov (http://www.clinicaltrials.gov) to find a study designed to treat your specific disease or condition. Each clinical trial will have a specific type of stem cell and treatment protocol, so banking your adult stem cells in advance might not be the right choice. Clinical trial study designs are not typically flexible, so I would suggest that you find a clinical trial first and they will handle the procurement of the stem cell and banking if the treatment protocol calls for it.
If you just want to bank your stem cells for the hope for the future, it is definitely possible. Banking them for an unknown use for the future might be comforting, but many clinical trials are designed with fresh, unfrozen cells. If you bank in advance, the doctors might still need to procure fresh cells to align with the study design.

Q: Would there be a certain age threshold that would make banking one's cells irrelevant? In other words, is someone who is 70 years old or older, is there any reason they would want to bank cells?
A: There is data, primarily with bone marrow derived stem cells, that suggests a decreasing benefit in stem cells with increasing age. There is somewhat encouraging data that this may not be true of Adipose Derived Stem Cells. The number of stem cells seems to stay constant and as much as 500-1,000 times greater than similar aged patients have in bone marrow. More research is required to determine the functionality of the stem cells when being used for treatment.
There are some encouraging data about ways to overcome the decline in function with age. However, we always describe the difference in chronologic vs physiologic age in terms of overall functional capacity and not just how many years they have spent on earth. More research is necessary to properly answer your question, but it does appear that in general, younger is better.

Q: Right to Try is one project that the Goldwater Institute has designed - "States should enact “Right to Try” measures to protect the fundamental right of people to try to save their own lives. This initiative would allow terminal patients access to investigational drugs that have completed basic safety testing, thereby dramatically reducing paperwork, wait times and bureaucracy, and, most importantly, potentially saving lives." The Goldwater Institute is in Phoenix which is near Gilbert where the Translational Stem Cell Therapy Foundation is located. Since you are active with this non profit foundation, does the foundation have any plans to coordinate or help the Goldwater Institute in getting this law implemented in all 50 states and to insure that it includes stem cell treatment?
A: The Translational Stem Cell Therapy Foundation has no current plans to coordinate with the Goldwater Institute on this issue. I don’t know of any plans to take an active stance on this issue, but I personally agree with the intent of the law, especially with different types of autologous cells which pose almost no negative risk or direct side effects. The FDA has been notoriously very conservative and restrictive in approvals. One thought would be to simply approve any therapy that has been approved in Europe.

Q: Does the Celebration Stem Cell Center offer treatments for patients? If so, what diseases are currently being treated?
A: The Celebration Stem Cell Centre is not a treatment center. They offer umbilical cord blood banking, Adipose tissue Banking, dental pulp derived stem cell banking, and Contract research.

Q: There have been different ideas kicked around about how to fast track stem cell therapies into the clinic in the U.S. Are you in favor of a new regulatory model that would accomplish this or are you satisfied with the current FDA approval process? If you favor a new model, what type of regulation or change would you like to see?
A It is embarrassing to imply that we must try therapies in Europeans before we allow it in real people in the US. This stance has caused delays as long as 3-5 years in getting US approval for many devices and therapies approved in Europe. Unfortunately, we live in a very litigious society and many people will sue to make a quick buck! Safety is the main focus, so I believe that if a stem cell procedure is proven to be safe, then people should have the right to try it. The question then becomes how to define the word “safe”. I feel that if the patient wants to try a “safe” procedure, but the benefit is unknown, they should be free to make their own decision.

Q: What point is there in banking my stem cells if the FDA won't allow me to use them? Is it legal if I did bank them to take them offshore to a clinic if I needed to use them?
A: Many people bank their stem cells with the hope of a new medical breakthrough in the future. If the stem cells are processed using techniques considered to be “minimal manipulation”, it would allow a greater potential to use the cells in the future. Most stem cell therapy is conducted in the United States under the classification of “clinical research”. Stem Cells can be used legally in the United States, if part of an investigational clinical trial. U.S. based stem cell banks are only able to release the stem cells for treatment if the procedure is approved in the country where the treatment takes place. Some countries require additional testing, which may or may not be done at your U.S. Stem Cell Bank. I would advise that if you are interested in receiving stem cells that they be drawn where the therapy would be done off shore.

Q: I've always worried that if I banked my cells and the company where I banked them went out of business, what would happen to them? Are there consumer protection laws that protect individuals who bank their stem cells?
A: Most stem cell banks have language in their contracts that states that they have to transfer the banked stem cells to another company if they go out of business. I would suggest asking that question and make sure the question is answered in writing by the stem cell bank of your choice.

Q: Does the Foundation ever provide grants or funds for patients who would like to put together a small clinical trial? I know there is a group of patients that is funding a clinical trial for Parkinson's disease.
A: I think it's a great idea, but a medical doctor would have to be the lead for this type of initiative. Every clinical trial has a Principle Investigator or “physician in charge” who is ultimately responsible for the safety of the patients enrolled in the trial. As you mentioned, this is a very difficult path for patients or families given the FDA efforts to limit or prevent these initiatives. Many foundations are set up to help offset the out-of-pocket costs for patients to get the therapy. Even if health insurance covers the procedure, the patient’s costs can be very high.

Q: I had adipose treatment and will probably have a few more, but each time I have to have the liposuction procedure done. It's not the most fun thing to do. I know the FDA won't allow stem cells to be expanded, but why couldn't extra fat be taken on the first treatment and then the stem cells stored or are the cells required to be used right away?
A: There is a lot of interest and efforts targeting banking of fat cells for all the reasons you mention. Stem cells derived from adipose tissue can be banked, but the clinical trial would need to be designed for the "follow-up" treatment dose of cryopreserved stem cells. I believe that banking the extra fat for the prospective use in the future would be a cost effective option. Keep in mind that they could only be used if the method of processing and freezing aligns with the protocols of that specific clinical trial. That may change in the future, so if the cost of banking the extra stem cell is nominal, it might be worth the risk. One option might be to bank the whole fat, without any additional cell processing or isolation of the cells. Many banks are able to offer either service, so as technology evolves, your stored fat can be processed at a later date with the new technology.

Q: Once stem cells are removed from the bank, is there a "shelf life"? How do you transport the cells to the doctor who is performing the transplant? What if the shipment got lost? Are any retained at the bank or would a person just be up a creek so to speak?
A: Proper handling of the stem cells during transport to the clinic is critical. The stem cell bank coordinates directly with the treatment center and a professional medical courier is typically used. The shipping methods vary, depending on the banking conditions. Some stem cell transporters are filled with Liquid Nitrogen and others can be shipped using dry ice. The stem cell bank is required to validate the shipping methods by tracking temperature fluctuation. The "shelf life" will be dependent on the shipping method, but typically will be dictated by how long the shipper can hold proper temperature. The stem cell treatment typically takes place immediately after the stem cells are thawed. No one is perfect and packages do get lost! Many banks store the stem cells in multiple storage containers, so it is possible that a "back-up" dose of stem cells may still be at your bank. That is a good thing to discuss with the stem cell bank; otherwise you might find yourself up that creek, so to speak!