May 30, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: amniotic

2 min read

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 got dubious “amniotic stem cell” material. From the FTC announcement: “According to the agency’s October 2018 complaint, Dr. Bryn Jarald Henderson, D.O. and the companies he owns and operates, …Read More

2 min read

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 the clinics, perhaps most of them, inject into patients is really a “dead” extract of amniotic membranes instead. Not living cells.  Are the clinics injecting amniotic stem cells or …Read More

2 min read

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 judge’s order. In its inspections, the FDA reported that it found some of the products were contaminated with pathogens. The company apparently disputes some aspects of the FDA’s claims …Read More

1 min read

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 could be due to the FDA warning. An archive of the site (screenshot above) provides information on their products. Notably, CBER described the company’s products as unapproved biological drugs …Read More

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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 the medical providers at the clinic?” There are indications that these physicians are Drs. Tushar Goradia and Clarence Lee. I first noticed Nervana because of full-page ads in the local …Read More

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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 that they appear to sell amniotic and fat stem cell injections for pain and joint conditions. I’m not convinced that such therapies are safe and effective, but the number …Read More