perinatal stem cells

Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

September 21, 2023 / By / 3 Comments
Burst Biologics, Christopher Jones

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 / By / 7 Comments
Dr. Leonid Macheret, FDA warning

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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End of FDA “grace period” impacted perinatal cell therapy biotechs

May 5, 2022 / By / 1 Comment
knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …

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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

February 1, 2021 / By / 10 Comments
FDA-untitled-letter

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …

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Bad Batch podcast’s dark picture of perinatal stem cell industry

March 2, 2022 / By / 4 Comments
John-Kosolcharoen-Liveyon-Bad-Batch

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have …

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FDA warns another perinatal stem cell supplier Stemell

February 1, 2021 / By / 1 Comment
Stemell-logo

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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‘Bottom of stem cell barrel’? Utah piece sparks legal threat

June 3, 2021 / By / 3 Comments
derek-lowe-e1564527793287

Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear …

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

October 26, 2021 / By / 25 Comments
R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a …

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FTC returns half a mill to consumers of “deceptively marketed amniotic stem cell therapy”

February 1, 2021 / By / 4 Comments
Bryn-Jarald-Henderson-D.O.-

There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front. Now the FTC has announced that more than half a million $USD have been returned to consumers who …

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