July 10, 2020

The Niche

Knoepfler lab stem cell blog

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