Search Results for: warning letter

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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Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell

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Regener-Eyes, eye drops

It’s mostly been a week of good and encouraging news in the regenerative medicine space including with gene therapies maybe with the exception of some eye drops warnings (more below). There’s realistic hope for an approved sickle cell disease soon. I also see some long-term positive news on hearing loss research. Hematopoietic stem cell transplant

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Why did Duke autism team halt its troubling pay-for-play program?

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Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a

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Review of where Kimera Labs fits into sphere of exosome companies

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Kimera labs exosome

Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes

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WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

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I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling.  Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How

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Why stem cell culture medium composition is such a big deal

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Dr. Harry Eagle

Cells including stem cells are grown in liquid solutions called media and stem cell culture medium composition is crucial since the ingredients have a powerful impact on the cells. The media affects the cells’ identities and functions. It also impacts the risks of using specific regenerative products. My first job in science was isolating and

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