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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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What is stromal vascular fraction or SVF?

July 21, 2019 / Professor Paul Knoepfler, Ph.D. / 26 Comments

When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years

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In dark augur for clinic industry, court allows class action suit by 100s against Stemgenex

June 30, 2019 / Professor Paul Knoepfler, Ph.D. / 7 Comments

In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex. (update: Stemgenex has since filed for bankruptcy). What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic

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Clinic biz US Stem (USRM) may be kaput in matter of weeks or months

March 10, 2019 / Professor Paul Knoepfler, Ph.D. / 7 Comments

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further,

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Up your nose? OMG Facebook video moments from clinic sued by DOJ

May 14, 2018 / Professor Paul Knoepfler, Ph.D.

If a picture is worth a thousand words, how about a Facebook video from a stem cell clinic? In my view it sure tells a story with some unusual twists. I wrote last week about this Facebook video by Kristin Comella, the leader of the publicly-traded stem cell clinic firm US Stem Cell, Inc. (USRM). As

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FDA warns Mother Stem Institute & Alvaro Skupin

September 10, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin. Background: Mother Stem Institute past issues I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was

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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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Weekly reads: R01 grant trends, DPPA4, adult human neurogenesis debate

November 21, 2021 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Great ideas and talented scientists are not enough as biomedical research needs funding and here in the U.S. that means having R01 grant success. The trends since 1995 are slowly heading the wrong way. The average age of getting your first R01 grant keeps getting older. There is also still a bit of a possible

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Groundbreaking Organoid Vision Clinical Study: Takahashi Q&A

July 8, 2020 / Professor Paul Knoepfler, Ph.D. / 8 Comments

Organoid based clinical trials are still rare and a Clinicaltrials.gov search for such organoid work largely brings up in vitro studies. A new clinical study in Japan where organoid material will actually be transplanted into patients is causing a lot of excitement. Organoid clinical trial Masayo Takahashi (高橋政代) is a pioneer in stem cell-based

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