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? This is 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 …
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 »
The Mayo Clinic does some great research on stem cells and regenerative medicine. However, at times I’ve felt that a few Mayo researchers are overexuberant. This mainly relates to certain not-yet-proven stem cell and related offerings. Fitting with that perception, the Mayo website also has some inaccurate stem cell content that leans toward overstating things. …
Key Mayo Clinic stem cell webpage is overexuberant & outdated Read More »
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 …
Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial Read More »
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 …
20 stem cell & regenerative medicine predictions for 2024 Read More »