July 12, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: amniotic

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

How much does a stem cell treatment cost? $5,000 is a nice round number that is probably close to the mark on average, but the price varies a great deal and depends on many factors. Factors that influence perceived average price include what one actually sees as being under that umbrella term “stem cell treatment.” Does the transplant from a stem cell clinical trial count as a “treatment”? I’m not sure it should, but many view it as qualifying for that definition. By and large, you …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

6 min read

Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More