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Stem cell clinic supplier Liveyon tries to regenerate itself after FDA recall

October 30, 2018 / Professor Paul Knoepfler, Ph.D. / 33 Comments

You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick. Since it seemed like this recalled product was […]

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FDA recalls Liveyon stem cell product: blow to big clinic supplier?

October 9, 2018 / Professor Paul Knoepfler, Ph.D. / 33 Comments

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up

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Weekly reads: Vertex stem cells for diabetes, storing iPS cells on the Moon, science hype award nominees

September 1, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Felicia Pagliuca, stem cells for diabetes

How is research looking on stem cells for diabetes? I’m feeling more encouraged about the clinical research in that area. Before we jump into that let’s talk about two other things. The big news of the week was the felony plea deal by Liveyon’s John Kosolcharoen to charges related to marketing an unapproved cell therapy

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Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

June 4, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Perinatal Stem Cell Society email material.

I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah

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Weekly reads: FDA OKs 2 gene therapies for sickle cell, new Paolo Macchiarini series, Fujifilm

December 10, 2023 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Marie Tornyenu, Casgevy gene therapies for sickle cell

The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for

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

October 5, 2023 / 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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Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

September 21, 2023 / Professor Paul Knoepfler, Ph.D. / 3 Comments

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The

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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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Why stem cell culture medium composition is such a big deal

January 12, 2023 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Cells including stem cells are grown in liquid solutions called media and stem cell culture medium composition is crucial since the ingredients have a powerful impact on the cells. The media affects the cells’ identities and functions. It also impacts the risks of using specific regenerative products. My first job in science was isolating and

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Desperately seeking stem cells: celeb quests for elixirs often mislead

January 10, 2023 / Professor Paul Knoepfler, Ph.D. / 3 Comments

What could go wrong with celebrities desperately hunting for stem cells as a fountain of youth? A flaskful of problems. Some famous folks can’t seem to get enough of stem cells, even if those supposed therapies are unproven and risky. In recent years, dozens of celebs have gotten stem cell procedures of various kinds. The

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