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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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Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions

August 8, 2023 August 21, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several …

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Weekly reads: stem cell for hair loss, clinic lawsuit update, 2 big retractions

June 11, 2023 June 12, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

There seems to be a never-ending supply of stem cell for hair loss research but a new article invokes a novel mechanism. Stem cell for hair loss research and cell mechanics Here’s a recent news item about a PNAS paper: Coaxing hair growth in aging hair follicle stem cells, NW Now. A common theme is things …

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2023 stem cell & regenerative medicine predictions

December 28, 2022 December 28, 2022 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they …

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Weekly stem cell reads: bat stem cells, brainier organoids, more

October 2, 2022 October 2, 2022 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

I’m working to send out a big grant on Tuesday so I’m busier than ever but a few stem cell and regenerative medicine stories caught my eye. I can’t write grants 24/7 without a few breaks although sometimes it feels like that’s what I’m doing. Bat stem cell derivation Pluripotent bat stem cells as a …

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Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics

September 4, 2022 September 3, 2022 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on …

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Did COVID derail FDA stem cell clinic plan?

June 30, 2022 June 29, 2022 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven …

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Thoughts on death of stem cell clinic leader Dr. Mark Berman

May 18, 2022 May 23, 2022 / By Professor Paul Knoepfler, Ph.D. / 18 Comments

Over the past dozen years as I’ve written about stem cell clinics here on The Niche I’ve gotten to know many of those running the clinics including Dr. Mark Berman of Beverly Hills. It was therefore kind of a shock to learn that Berman died of last month. Michael Hiltzik of the LA Times reported …

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16 predictions for stem cells & regenerative medicine in 2022

January 4, 2022 January 9, 2022 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

The last few years in the stem cell and regenerative medicine arena have been complicated in many ways. Variables like surging stem cell clinics and COVID have made predictions harder. Even so, trying to make predictions is useful and it’s fun to go over past year’s predictions. You can see my scorecard on my 2021 …

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