stem cell clinics

New York wins $5.1 million in suit against Manhattan stem cell clinic

Park Avenue Stem Cell

There are so many stem cell clinics out there that it can be hard to keep track of them and the news about them, but a big court victory against a Manhattan stem cell clinic by New York State Attorney General Letitia James is notable for several reasons. Injunction on Park Avenue Stem Cell clinic …

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

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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Stem cell therapy side effects: infections, tumors & more

stem-cells-eyes side effects

What are the possible stem cell therapy side effects when people are considering going to an unproven clinic? This is a common question I get asked by patients who reach out. For a video version of this post check out the YouTube video below on our stem cell channel. If you like such videos please …

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Clinics turning to potentially dangerous intranasal stem cell delivery

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

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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