January 18, 2021

The Niche

Trusted stem cell blog & resources

amniotic stem cells

4 min read

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest untitled letter went to RichSource Stem Cells, Inc. and its CEO Sara Oracle, a firm which markets an unusual “combo” product described this way by the FDA, “a combination …Read More

2 min read

I’m relatively new to podcasts, but am enjoying a new stem cell-focused one called Bad Batch by medical journalist Laura Beil, which I’ve been listening to in the car as I commute. I just finished episode three. I’m curious to hear how the next few episodes of the story unfold. I talked and emailed with Beil as she worked on this project. Her rigorous approach impressed me and she clearly did her homework on it. Bad Batch comes from podcast network Wondery. It is …Read More

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

4 min read

The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections. One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other …Read More

3 min read

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up more often in the unproven stem cell clinic industry recently. More specifically, they seem to be a supplier and marketer of birth-related products to clinics. The clinics then in …Read More

5 min read

Hat tip to North Dakota! You probably know by now that there are stem cell clinics in just about every state in the U.S. and some states and metro areas are hot spots. Heck, some of you reading this probably run such clinics. But did you know that of all the states, arguably North Dakota has handled a stem cell clinic situation better than any other so far? And this has big implications for stem cell clinics across the U.S. You can see my …Read More

5 min read

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America. Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in …Read More

3 min read

There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here? What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated map showing the spread of stem cell clinics selling non-FDA approved “treatments” across the U.S. would be useful. With publication of our new paper, the recent work of Leigh Turner …Read More