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FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms

December 9, 2019 / Professor Paul Knoepfler, Ph.D. / 13 Comments

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day […]

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Right To Try law has a big loophole that’s an opening for bad actors

October 7, 2019 / Professor Paul Knoepfler, Ph.D. / 14 Comments

There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend

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KING 5 TV pulls odd Swedish Medical regen med infomercial off YouTube

April 2, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Swedish-Adam-Pourcho-Regenerative-Medicine

Some unproven stem cell clinics just make things up, but when a big medical organization like Seattle’s largest nonprofit health firm, Swedish Medical Group, has a marketing segment on TV with what in my view are odd and inaccurate claims related to regenerative medicine, the negative impact could be far greater. The segment in question

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Have you given up on your local paper? I might with The Sacramento Bee

March 5, 2019 / Professor Paul Knoepfler, Ph.D. / 7 Comments

For more than a dozen years we’ve subscribed to The Sacramento Bee newspaper here in Northern California. During those dozen+ years, newspapers across the U.S. have been under huge financial pressures. At a science level, one of the terrible results of this pressure on newspapers has been the vast number of excellent science writers who

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Report a bad clinic

November 8, 2018 / Professor Paul Knoepfler, Ph.D.

The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see or have had a bad experience with a stem cell clinic

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FDA outlines potential crackdown on Clinicaltrials.gov offenders

September 23, 2018 / Professor Paul Knoepfler, Ph.D. / 11 Comments

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance

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Fun pictures & 7 observations on the country from Australia trip

July 16, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

What’s Australia like from the science to the country? I enjoyed the ISSCR2018 Annual Meeting in Melbourne on stem cells and regenerative medicine a few weeks back(here is a post on the some of the notable science from Day 1), but I also got a chance to get to know Australia a bit too. Below I have

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Civil Lawsuits as a Public Health Strategy: Can Cases Brought by Injured Plaintiffs have a Broader Effect?

March 12, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

By Claire Horner In 2016, a law firm in California began looking for individuals who were “misled or harmed by stem cell treatment” in the southern California area (which was discussed on this blog here). While there had been other lawsuits filed by plaintiffs against individual clinics, this firm was looking to take a different

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Just one word placentas: Can Celularity live up to hype?

February 20, 2018 / Professor Paul Knoepfler, Ph.D. / 5 Comments

I’ve been blogging about stem cells now for about 8 years and the recent level of hype about and fluffy media coverage of Celularity, the biotech spun out of Celgene, ranks right up here with the most extreme past cases I’ve seen. What is Celularity and who is its leadership? It’s a new biotech focused

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Updated FDA granted RMAT List (130)

January 10, 2018 / Professor Paul Knoepfler, Ph.D.

Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. I also include FDA data on RMAT submissions via an FDA RMAT resource page. At this point as of May 2025, I have found

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