DAVID GRANOVSKY

The FDA vs Adult Stem Cells

In ALL ARTICLES on August 7, 2010 at 2:24 pm
A battle has been raging for quite some time without you even knowing it…

The FDA vs Adult Stem Cells


Adult stem cells have many supporters; many doctors, patients and scientists who want to see adult stem cells available in the US.  One of those supporters doing battle on the front lines is Chris Centeno, M.D. of Regenerative Sciences.  The FDA and Centeno have been doing battle for quite some time now…

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Feb, 11, 2009

Here is a letter from Chris Centeno, M.D. of Regenerative Sciences dated February 11, 2009 9:47:00 AM PST:

To set the record straight, the FDA sent us an “untitled” letter, not a warning letter. Their own information states that such a letter is to be sent when the FDA is unsure of it’s regulatory authority. We responded to this letter some 6 months ago and the FDA has not responded to our answers to their concerns.

We run a state of the art medical facility that has undergone a full, voluntary Reglera cGTP review and passed with flying colors. The medical procedure performed within our facilities compares very favorably with the ISSCR guidelines. While you bring up some interesting points, embryonic stem cell expansion is performed everyday in countless non-FDA regulated In-vitro Fertilization labs in the US, without issue. The practice of culture expanding autologous bone marrow cells to reconstitute the immune system of irradiated cancer patients is just beginning, again without FDA involvement and usually under the auspices of state regs.

Our procedure was first successful in a university based, large animal model. We spent a year porting that to human patients under the auspices of an Institutional Review Board (IRB).. We began treating commercial patients only after an additional year of IRB approved research (which continues). We don’t add new areas of treatment until after our research has shown imaging and patient reported evidence of efficacy and safety. As a concrete example, my initial interest as a pain management specialist was treating lumbar degenerative discs. However, just copying the successful animal model into humans didn’t work. It took three years of tweaking the procedure until we could get it to work reliably in a subset patients. Hence the procedure for discs wasn’t begun on commercial patients until recently and then only with specific inclusion criteria. As a result of these experiences of what will likely work and what won’t work, we categorize all patients as either GOOD, FAIR, or POOR candidates based on pathology. As an example, only about 25% of our joint patients are prospectively placed in the GOOD category, 50% in FAIR, and 25% in POOR.

We also employ a nurse to maintain a patient tracking database that is >3 years old and now contains 200+ patients, 50 or so of these have also had pre and multiple post-op 3.0T MRIʼs of the transplant sites. This safety data has been submitted for scientific publication. So while I donʼt dispute that like anything in medicine, practitioners can enter the field who may not be reputable (i.e. a surgeon who is not well trained or an IVF lab opening that doesnʼt do a good job of handling cells), we take our practice of medicine very seriously.

Chris Centeno, M.D.

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Aug. 6, 2010

I suppose it was inevitable that the FDA come after Regenerative Sciences. -dg

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product


So, what was Regenerative Science’s response to this attack? -dg


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