In 2005, the Panama College of Cell Science was formed to train scientists and clinicians in the new medicine of adult stem cell therapy. The College offered the only PhD program at that time which contained any courses espousing the benefits of adult stem cell therapy, and presenting the advancements in adult stem cell therapy that were occurring world-wide.
At that time, for many scientists and resesrchers, it would have been a career ending decision to study the potential of adult stem cells, because the tenor of the times was that only Embryonic Stem Cells (ESC), not Adult Stem Cells (ASC), would lead to patient therapies and cures. How wrong those embryonic stem cell scientists were. While the world marched on proving time after time the control and cure of our most debilitating diseases with autologous (adult) stem cells, the US sat idly by, in the grip of the “ESC’s are better than ASC’s” crowd.
In 20 years, not one therapy based on embryonic stem cells has ever been created. Not one. Like we say to our students in one of our courses, find any report of any useful therapy using Embryonic stem cells and collect your “A” for the course. No student has ever collected an”A” on that basis since we started in 2005.
To say that the FDA has been obstructive in blocking this new therapeutic modality that many call the “new medicine” is to recite the obvious. Rather than assist this new field, the US Food and Drug Administration seemed many times hell bent on stopping it.
But slowly over the last 20 years, more and more physicians took small steps and tried some stem cell therapies with positive results. They shared with their colleagues. Little by little there came to be a feeling among medical professionals, though largely underground, that Yes, there may indeed be something important going on with respect to the healing powers of adult stem cells.
Even some politicians began to wonder why stem cell therapies were not being supported by the US Government and its enforcement arm, the FDA. See for example Congressman Berkley Bedell’s excellent essay “Why Can’t We Use Our Own Stem Cells?”
The Congress of the United States held hearings, heard from patients whose lives had been improved by stem cell therapy, many of whom had to go overseas, and finally acted in a big way. In December 2016, the 21st Century Cures Act was enacted into law mandating that the FDA consider new biological therapies. We here at the College recognized immediately that this new law in fact authorized stem cell therapy in the United States.
It has taken awhile for the regulators to write rules for the new law, and the rules are still in the works. But a recent article in the New England Journal of Medicine demonstrates a sea change in the regulatory framework and in the FDA’s approach.
(1) The new law has been interpreted to permit new stem cell therapies if “preliminary clinical evidence of efficacy” can be shown. This is a very low bar to have to reach, made lower by the requirement that the FDA must consider “the submission of patient registries (another word for patient testimonials) or other sources of real-world evidence”, i.e. beneficial results of stem cell treatments overseas.
(2) A moratoriam on enforcement action was placed into effect and which expires November 2020. The purpose of the moratorium was to allow practitioners to develop any evidence of efficacy so as to file for permission to use the new stem cell therapies after 2020.
Finally, we have some terrific people in charge at the FDA, and the agency is now primed to assist the development of these new biological modalities. The paper, authored by then FDA head, Scott GottlieB , M.D. and Peter Marks, M.D., Ph.D. FDA Center for Biologics Evaluation can be found HERE:
Any brief look at the internet and also as to papers being published shows that we are witnessing an explosion of activity using adult stem cells and stem cell fractions for the treatment of diseases and conditions. Many physicians are attending training sessions and incorporating stem cell treatments in their practices. Many novel ideas for therapies are being tried out during the moratorium which if shown to have ANY beneficial effect, will be fast tracked for approval and use in the US.
We at the Panama College of Cell Science have no doubt that the tide has turned and that adult stem cell therapy in the US will now rapidly move forward. After 20 years of sitting and watching the rest of the world use adult stem cells effectively, the US will now become the leader in stem cell therapy.
Hopefully, the expansion of stem cells will also become allowed. The multiplication of stem cells prior to injection to the patient is required to obtain sufficient numbers of cells to cause a therapeutic result in many cases. As autoloogus stem cells from a patient can be multiplied (expanded) in the same patient’s serum, there is no reason why this advanced methodology should not be permitted as well. Expansion of autologous stem cells in autologous serum. That’s what we would like to see approved!
The new bell ringing in the halls of Congress that we hoped for, has finally rung! We are witnessing a new era in medicine in the US, the era of patient-specific medical cures using stem cells and other related biologicals.
The Panama College of Cell Science
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