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 […]
Regener-Eyes maker gets FDA warning on amniotic eye drops Read More »
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
Man could get 240 yrs for amniotic fluid for knees Medicare scam Read More »
There’s a lot of questionable “stem cell” injections these days involving purported amniotic stem cell or other perinatal (birth-related) material. Regulators are taking note including the FTC, which took some unprecedented action last year on this front. Now the FTC has announced that more than half a million $USD have been returned to consumers who
Some amniotic stem cell clinics seem to be trying to have their cake and eat it too. Generally the amniotic stem cell clinics market their products as “stem cells” and the implication is that living stem cells are used to effectively treat many medical conditions. I have not seen it mentioned that what some of
Wanted both dead & alive: amniotic stem cell clinics sell zombie cells? Read More »
The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the
Federal judge blocks FDA action on Texas amniotic supplier Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Read More »
Remember Nervana Stem Cell Center, an amniotic stem cell clinic here in the Sacramento area, which I’ve posted about before here and here. One big question about Nervana remains unanswered: is its apparent marketing of amniotic stem cells for arthritis and other conditions is OK with the FDA? Another question has been, “who are the medical
Sacramento amniotic stem cell clinic advertises again, but by another name Read More »
I was eating my Sunday breakfast and reading the SacBee, when a full-page ad for a stem cell clinic jumped out at me. I dropped my toast onto the plate and grabbed my iPhone to take a picture. The ad is for Nervana Stem Cell Centers in Sacramento. A little research on their website revealed
Fat & amniotic stem cell clinic Nervana opens in Sacramento Read More »
Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,
This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve
Big spike in FDA warning letters to unproven biologics firms Read More »