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Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

December 16, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in […]

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Bad Batch podcast’s dark picture of perinatal stem cell industry

November 20, 2019 / Professor Paul Knoepfler, Ph.D. / 4 Comments

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have

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Report from Medical Board of California meeting on stem cell clinics

September 18, 2019 / Professor Paul Knoepfler, Ph.D. / 17 Comments

Dr.-Charity-Dean-California-Med-Board-stem-cell-clinics

This afternoon I attended and gave public comment at the Medical Board of California stem cell task force meeting on unproven stem cell clinics. There were about 40 people attending. In part this meeting is a consequence of the national governing organization of state medical boards, the Federation of State Medical Boards (FSMB) having worked

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StemGenex clinic bankruptcy reveals surprises including huge revenue

September 11, 2019 / Professor Paul Knoepfler, Ph.D. / 6 Comments

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end

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FDA warns another perinatal stem cell supplier Stemell

September 10, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain

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Northwestern abruptly ending Burt HSCT autoimmune trials

August 29, 2019 / Professor Paul Knoepfler, Ph.D. / 56 Comments

“HSCT Chicago Clinic Closing!” is the startling header in all caps on a patient-run Facebook page about a stem cell therapy clinical trial program at Northwestern University. What’s going on? Unfortunately, the promising field of hematopoietic stem cell transplantation (HSCT) for multiple sclerosis (MS) and other autoimmune diseases seems to have suffered an unexpected setback

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StemGenex, unproven clinic sued by patients, morphs into Advanced Cell Medicine?

June 19, 2019 / Professor Paul Knoepfler, Ph.D. / 4 Comments

The unproven stem cell clinic StemGenex appears to now be called Advanced Cell Medicine. StemGenex is facing a proposed class action lawsuit by patients and it also recently received an FDA warning letter. StemGenex is notable too in that it seemed to be considering taking some extreme action against perceived critic websites including potentially the

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Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

June 3, 2019 / Professor Paul Knoepfler, Ph.D. / 26 Comments

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

May 30, 2019 / Professor Paul Knoepfler, Ph.D. / 26 Comments

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a

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FDA needs to quickly act against IRBs enabling risky fat stem cell clinics

March 31, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by

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