Search Results for: lawsuit

Recommended reads: police act on phony autism cure, Aspen starts Parkinson’s trial, reprogramming to iBlastoids

stem cells for autism

People often ask me about stem cells for autism or even their hope of an autism cure. I’ve explained that there is no new treatment for autism based on stem cells. There aren’t even mildly encouraging data. Note that it can be hurtful to the community to talk about an autism cure and disregarding neurodiversity. […]

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Georgia AG & FTC win Superior Healthcare stem cell clinic case, seek $17 million

STEVEN D. PEYROUX, Georgia stem cell clinic

An unproven Georgia stem cell clinic called Superior Healthcare and other co-defendants recently lost a key court case. Some of you may remember that the Attorney General (AG) of Georgia Chris Carr and the FTC have been collaborating on this case. Now we have the good news that they have won the case via a

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9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging?

Cell Surgical Nework

I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case

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Weekly reads: Xist & autoimmune disease in women, Crohn’s disease, dumb headline of the week

Xist ,auto immune disease

Readers of The Niche have asked me many questions about stem cells for autoimmune disease but the puzzle of why women get these conditions more often than men hasn’t come up before here. For instance, why is MS so much more common in women than men? It’s remained somewhat of a mystery over the years.

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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter

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20 stem cell & regenerative medicine predictions for 2024

Stem cell, crystal ball, predictions

Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please

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2023 stem cell predictions grades reflect wild year for regenerative medicine

stem cell predictions

Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you

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

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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Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

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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Weekly reads: big Retraction Watch news, stem cells & metastasis, an FDA approval, Iowa AG sues clinic

Retraction watch

Retraction Watch has been a great resource for those of us who have been following research misconduct. They widely cover and conduct research on retractions, corrections, and other developments in this space. Unfortunately, there’s been plenty to write about even just within the stem cell and cell therapy arena, which is my primary interest. Think

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