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

August 21, 2023 / By / Leave a Comment
Dr. Antonio E Blanco MD, US Stem Cell

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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Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial

August 3, 2023 / By / 1 Comment
mesoblast ceo dr silvio itescu

Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment …

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Weekly reads: HIV from vampire facials, CAR-T, FDA warns Regenative Labs

July 15, 2023 / By / 3 Comments
vampire facials

Imagine regularly having someone rub your face all over with the equivalent of a small roller covered with spikes and doused with either your blood or someone else’s and you have what’s called vampire facials. There’s more news that this is a very bad idea. Vampire facials linked to more HIV cases “Vampire facials” promoted …

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Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells

April 22, 2023 / By / Leave a Comment

It’s a big challenge to get a cell therapy approved by the FDA and if you look at my list of FDA-approved stem cell therapies, it’s not as long as we might hope. FDA OK on cell therapy from Gamida Cell For this reason, it was excellent news to see that the FDA approved a …

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Weekly reads: Sarepta, epigenomics, FDA on eyedrops

April 15, 2023 / By / Leave a Comment
Sarepa CEO interview.

The biotech Sarepta has had a complicated go of it with the FDA sometimes related to their Duchenne muscular dystrophy (DMD) gene therapy efforts. In late 2016 I wrote about how there was some controversy as the FDA approved the Sarepta drug eteplirsen (Exondys 51) also for DMD, going against an advisory panel that had …

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3rd Invitrx warning highlights FDA oversight weakness

January 4, 2023 / By / 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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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

December 14, 2022 / By / 7 Comments
ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II …

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FDA appeals Cell Surgical Network lawsuit verdict

October 31, 2022 / By / 7 Comments
Cell Surgical Network stem cell clinic chain

The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict.  It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal …

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

November 23, 2022 / By / 3 Comments
Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …

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