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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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25 stem cell & regenerative medicine predictions for 2025

December 17, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

regenerative medicine, stem cell predictions

Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms. In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include

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FDA warns Frontier Biologics as part of its more active trend

December 3, 2024 / Professor Paul Knoepfler, Ph.D. / 1 Comment

The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With

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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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