stem cell clinics

Translating the FDA’s Q&A on end of stem cell grace period

The Rosetta Stone, The FDA

The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers …

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Stem cell therapy: the good, the bad, & the muddy waters

stem-sells-marketing

How can you tell who to trust in the world of stem cell therapy? What information can a patient trust? Once upon a time about a dozen years ago it seemed a much simpler question. There were universities and biotech companies doing legit research as well as clinical trials, and there were physicians doing bone …

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Review of Bioinformant, unproven stem cell clinic promotion, NIH & Pfizer as clients?

Bioinformant stem cell t-shirt

A few years ago a promotional website called Bioinformant popped up in the stem cell arena. It’s very different in some ways than most other stem cell-related websites that I’ve seen. It’s a marketing and promotion site. What’s the backstory? I believe there’s reason for concern here specifically related to Bioinformant promoting unproven stem cell …

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New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a …

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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics …

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Weekly pubs & 2 stem cell clinics get bad news

markiewicz potoczny nature 2020 trf2 es cells

Even in COVID times the FDA continues its stepped-up efforts against stem cell clinics and patients are suing clinics more too, which I cover in today’s post along with recommended stem cell research pubs. One of the papers at the top of my to-read list is on 3D chromatin in stem cells. FDA Warning Letter …

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FDA OK’s more COVID-19 efforts of unproven stem cell clinics

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In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about …

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2 State AG’s sue ‘Stem Cell Centers’ clinics including for alleged fraud

Travis-Autor

Some readers suggested earlier this year that I look into a clinic firm called ‘Stem Cell Centers’ with its owner Travis Autor. I didn’t have time to do much since I’ve been very busy in the lab before the state Attorney Generals of Iowa and Nebraska sued them based on a number of allegations including …

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Who IS this!? Surprising phone survey of stem cell clinics on their COVID-19 pandemic status

iPhone-stem-cell-clinics-pandemic

It’s not every day that I call a bunch of stem cell clinics to say “hi”, but yesterday I called some of them during a needed lunch break from grant writing to see what they were doing about their operations during the COVID-19 pandemic. The impetus for this survey of a sort was a question …

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Stem cell clinic busted: police make arrests in Indonesia

Police-in-Indonesia-seal-off-an-illegal-stem-cell-clinic

Police in Indonesia have busted a stem cell clinic. They shut down an allegedly illegal stem cell clinic and made arrests of those working there including potentially the doctor. The clinic was located in Kemang, South Jakarta, but the clinic is not named and the personnel are listed by their initials including a Doctor OH. …

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