Search Results for: amniotic

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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Stem cell therapy cost in 2024: data & analysis

January 7, 2024 / By / 4 Comments
stem cell therapy cost

How much does stem cell therapy cost in 2024? How have prices changed? To authoritatively answer these questions now we need data from the present and past along with expert perspectives. Some surprises come up in this new analysis. In this article Intro  | Stem Cell Therapy Cost: $10,000-$20,000 | Why do stem cells cost so much? …

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

April 29, 2023 / By / Leave a Comment
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 warning (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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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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Does Medicare cover stem cell therapy? Mostly no & it’s poised to recoup tens of millions

January 19, 2023 / By / 2 Comments
Regenative labs, does Medicare cover stem cell therapy?

Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds …

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Fact-checking exosome therapy: costs, risks, & lack of data

November 27, 2022 / By / 5 Comments
model of an exosome, exosome therapy

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell …

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Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO

August 13, 2022 / By / Leave a Comment
Timothy D. Hunt, new CEO of ARM, Alliance for Regenerative Medicine

I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …

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Fact-checking troubling R3 Stem Cell clinic chain

November 16, 2022 / By / 12 Comments
Map of R3 stem cell clinic locations

I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …

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MO Rep Patricia Derges already indicted for alleged stem cell scheme, now sued by patient

May 25, 2022 / By / 1 Comment
patricia derges indictment for fake stem cells sm

The news just keeps getting worse for Missouri state lawmaker Patricia Derges, who was indicted last year by the feds for an alleged stem cell scheme. She is now also being sued by a former patient. Derges, who is not a physician but rather an assistant physician, was providing supposed stem cell or related biological …

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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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