December 4, 2020

The Niche

Knoepfler lab stem cell blog

amniotic stem cells

5 min read

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America. Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in …Read More

5 min read

According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles: “The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are concerns about alleged misrepresentations and questions over whether all available information is being given to potential patients.” A week and half is a short time so this particular state …Read More

6 min read

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in draft form. There will be a 90-day comment period for the latter. Are today’s developments a good thing overall? I’d say “yes”, although there are still some ambiguities and …Read More

3 min read

What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the California law. With more than 100 clinics in California as of last year marketing non-FDA approved “treatments” and this number apparently increasing, something needs to be done to protect …Read More