January 24, 2021

The Niche

Trusted stem cell blog & resources

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

1 min read

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

1 min read

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

7 min read

Each year I metaphorically try to look into a crystal ball for stem cell predictions for the coming year and I did so for 2020, but the COVID-19 pandemic threw a monkey wrench into my predictions. It actually kind of blew some up. It also raised some interesting questions and dilemmas. For instance, do many kinds of non-cellular research for COVID-19 count as “regenerative medicine”? What about COVID research as regenerative medicine? Some folks sure seem to think so. Witness our California state stem …Read More

4 min read

More states have taken action against stem cell clinic-related firms in the past year than ever before and now we can add Georgia to the list. Georgia adds to growing list of state AGs suing stem cell clinics The George Attorney General Chris Carr filed suit against several related firms (going by various names over time) and their owner, Justin Paulk. The firms listed as defendants in addition to Paulk as an individual include, “Elite Integrated Medical, LLC, formerly known as Superior Healthcare of …Read More

7 min read

Stem cell clinics and suppliers have been getting into the business of making promotional films to generate more revenue, but now there’s something very different in the cinematic stem cell arena called From Jail Cell to Stem Cell by filmmaker Doug Orchard. It is at its heart an exposé film about some in my view particularly concerning stem cell and exosome clinics and suppliers. The only other thing similar to this was 2019’s great podcast Bad Batch. Reviewing the movie From Jail Cell to Stem Cell Today’s …Read More

5 min read

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative medicine arena. I’ve linked to each announcement below with the agency’s title of the announcements. Underneath I provide some analysis and ask questions. I’ve also included some other stem …Read More