One of the problems in the stem cell field is that so few doctors have adequate training in stem cells (biology, transplantation, regulatory issues, GMP, ethics, patient rights, etc) and yet they are treating loads of patients in a for-profit setting.
This not puts patients at great risk, but also the physicians themselves are putting themselves at risk both in terms of punitive regulatory actions and patient litigation. More broadly the untrained practice of stem cell-based medicine puts the stem cell field at risk.
I have a new paper out in the journal Regenerative Medicine proposing that academic medical centers develop physician training programs in stem cell-based cellular and regenerative medicine. The paper is entitled: Call for fellowship programs in stem cell-based regenerative and cellular medicine: new stem cell training is essential for physicians.
I hope that medical schools and health systems across the country in the US will innovate to create these new training programs for physicians. What I envision is a 1-year program that covers the curriculum in the box above.
Such academic fellowship programs in stem cell-based cellular and regenerative medicine would go a long way to improving the safety and efficacy of this emerging new area of medical practice. They would likely reduce confrontations between physicians and the FDA as well as FDA regulatory actions.
Which University or Health System will be the true pioneer and have the first such program in the country? Whoever it is, they will have taken a very positive step for the field of stem cell-based medicine.
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Dr. K,
I have every intention of making this a reality if its not already by the time I’m an attending physician. It’s a long road, so for now, just plugging away with Joe and the folks at SSSCR. Please keep me posted if you hear of any fellowship developments that your post may have inspired! -Ankur
Great paper – thank you for sharing your work on regenerative medicine and cellular therapy.
Lack of consensus among the Physicians and The regulatory authorities seems to The major bottleneck.I beleive The physicians should be thoroughly immersed in The IRB issues,FDA régulations ,PHS act,GLP & GMP standards,stem cells,,cell therapies,Ethical issues etc
I am a consultant Orthopaedic Surgeon from HYDERABAD area,HYDERABAD,India.
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I Will be The first person to join fellowship course,whoever starts such a course in USA.
I applaud you efforts in getting MDs trained in cellular therapies and regerative medicine. I have been in this business for over 20 years and I have yet to see a trainign program for Cellular Therapy doctors. Physicians and PhDs need to know what is going on in the clinical laboratory not just the research lab. They need to be exposed to regulatory and quality standards that affect patient, donor, and product safety. At my last job the director hired a PhD from Immunology research. He cleared a whole Thursday afternoon to learn exactly what I do in the (public) cord blood bank, a FDA regulated biologic product. Sarah