July 10, 2020

The Niche

Knoepfler lab stem cell blog

Cell Surgical Network

5 min read

In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgment against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

6 min read

Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do? Below I grade my 20 predictions for this year. You can in addition see my grading of my 2018 predictions here. In the next week or so I’ll also …Read More

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