September 30, 2020

The Niche

Knoepfler lab stem cell blog

California Stem Cell Treatment Center

3 min read

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in supply. Why did Liveyon chose to halt sales at least for the moment? By comparison other clinic-related firms have continued business as usual despite various FDA actions against them …Read More

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

4 min read

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a lot of subtext in the FDA letter and accompanying PR, in my view none of it good for the company or its “centers of excellence.” The R3 website also …Read More

3 min read

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further, they are both filing motions asking for summary judgment and asked for more pages to make their respective arguments. Things are moving fast now. Everything is due tomorrow to …Read More