FDA warning letter Archives

Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

January 21, 2024 January 21, 2024 / By Professor Paul Knoepfler, Ph.D. / 10 Comments

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter …

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FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

October 5, 2023 October 8, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the …

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

August 31, 2023 August 31, 2023 / By 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 January 4, 2023 / By 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 February 1, 2021 / By 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 April 27, 2024 / By 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 February 1, 2021 / By 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 February 1, 2021 / By 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 February 1, 2021 / By 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 February 1, 2021 / By 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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