Search Results for: warning letter

Weekly reads: Altos Labs aging supplements pub, destructive NIH cuts, FDA warning, HSCs

Steve Horvath, Altos Labs

When I think of so-called aging supplements, visions of snake oil dance in my head. Possible benefits of supplements more generally have mostly not held up to long-term research. Supplements have risks too and so do purported longevity supplements. These pills claiming to fight aging are more in the realm of stem cell supplements that […]

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Weekly reads: NIH freeze even before RFK confirmation, FDA warnings, RP stem cell trial data

NIH freeze

RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze. What do I mean? NIH freeze could do lasting damage to biomedical research The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals. No study sections means almost no new

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Weekly reads: intermittent fasting and stem cells, vet warning, blastemas

intermittent fasting and stem cells

Intermittent fasting must be good for stem cells, right? It’s not so clear. Like many things in biology, intermittent fasting can have seemingly opposite effects. Before we get into that, the news of the week is that the FDA approved Mesoblast’s Ryoncil MSC drug for some cases of pediatric GvHD. This has sparked lively discussion.

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Regener-Eyes maker gets FDA warning on amniotic eye drops

Regener-Eyes

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis

stem cell shampoo

Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell

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Recommended reads: FDA warning on stem cells for pets, chromatin, aging & HSCs

Safari Stem Cell, stem cells for pets

When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else. We’ll get into all of that in a moment, but first, since

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Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells

SVF

One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That

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Weekly reads: Alzheimer’s & lipid droplets, stem cells for COPD, fecal tx warning, med school teaching

Alzheimer's, lipid droplets Alzheimer's

So many things go wrong during the lead up to clinically-evident Alzheimer’s disease. This complex disease pathway has, in turn, led to a vast array of approaches to try to treat or prevent Alzheimer’s. Most of these efforts one way or another have something to do with the amyloid plaques and tangles that accumulate in the

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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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3rd Invitrx warning highlights FDA oversight weakness

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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