Search Results for: warning letter

Recommended reads: gov scientists fear Trump 2nd term, MYCT1 in HSCs, in vivo editing

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Trump

I’ve only met one scientist who was openly a Trump fan, but I’m sure there are more out there. Still, it seems most scientists are no fans of the former president. A new WaPo piece highlights how federal scientists are worrying about a possible second term for the former president. Government scientists & a second […]

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Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

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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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Man could get 240 yrs for amniotic fluid for knees Medicare scam

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A Justice Department press release details how a physician’s assistant (PA) in Texas was convinced of fraud related to amniotic fluid injections. This story tells us some important things about how Medicare handles things versus the FDA approach to such things. Amniotic fluid scam A jury found Ray Anthony Shoulders, a PA at a pain

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Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

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AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

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Weekly reads: stem cells for epilepsy from Neurona Therapeutics, diabetes, contagious cancer

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Neurona Therapeutics, stem cells for epilepsy

People often ask me what are the most promising stem cell therapies in development and new data suggest we should add stem cells for epilepsy to the list based on work by Neurona Therapeutics. I’ll start off the weekly recommended reads with this new mouse paper on cell therapy for epilepsy. Neurona Therapeutics: stem cells

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FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

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Signature Biologics, Neil Riordan

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?

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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

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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

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

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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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