stem cell clinics

Turner pub charts runaway stem cell clinic industry; FDA needs to think big now

November 10, 2021 / By / 9 Comments
U.S. Stem cell clinics map 2021.

Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of …

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Clinics turning to potentially dangerous intranasal stem cell delivery

August 3, 2021 / By / 8 Comments
Intranasal stem cells trial map from Clinicaltrials.gov

Because of blogging here on The Niche and people giving me tips I often can see trends before they fully surface and a troubling new one is intranasal stem cell delivery by unproven clinics. Over the past year I have heard of many clinics now offering this approach. I’ve seen this in marketing and heard …

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

July 22, 2021 / By / Leave a Comment
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

July 20, 2021 / By / 7 Comments
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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New data on stem cell clinics, INDs, & more including from FDA itself

June 6, 2022 / By / 7 Comments
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

April 27, 2021 / By / 4 Comments
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

June 6, 2022 / By / 2 Comments
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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2 State AG’s sue ‘Stem Cell Centers’ clinics including for alleged fraud

February 1, 2021 / By / 2 Comments
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

February 1, 2021 / By / 9 Comments
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

February 1, 2021 / By / 6 Comments
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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