FDA warning letter Archives - Page 2 of 3

FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

August 31, 2023 / Professor Paul Knoepfler, Ph.D. / 7 Comments

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this […]

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3rd Invitrx warning highlights FDA oversight weakness

January 4, 2023 / Professor Paul Knoepfler, Ph.D. / 8 Comments

The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past

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Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT

June 23, 2020 / Professor Paul Knoepfler, Ph.D. / 7 Comments

The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent

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‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter

March 22, 2020 / Professor Paul Knoepfler, Ph.D. / 7 Comments

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning

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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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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

April 4, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the

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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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Stem cell clinic doc being sued by FDA now gets agency warning for unapproved breast device

February 20, 2019 / Professor Paul Knoepfler, Ph.D. / 12 Comments

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.

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FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

January 7, 2018 / Professor Paul Knoepfler, Ph.D.

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning

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What is the FDA’s appropriate role in regulating medical innovations such as stem cells?

February 24, 2014 / Professor Paul Knoepfler, Ph.D. / 4 Comments

We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on

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