As I’ve been writing this blog for the last couple years it has served as a catalyst for me to meet dozens of really interesting people. One such person is Lee Buckler, a true stem cell industry guru. Given all the complex events of late in the stem cell field, I asked Lee if he …
Great interview with Lee Buckler on stem cell industry, regulatory issues, and Celltex Read More »
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place. …
Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled Read More »
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic …
Grading my 2022 regenerative medicine predictions Read More »
Here are my recommended weekly reads for The Niche readership for early February 2021 including COVID-19 and stem cell lawsuit updates, papers, and more. How many papers do you end up reading each week or month these days? More or less than before the pandemic? COVID-19 updates New diabetes cases linked to covid-19, WaPo ICYMI …
The Niche reads: COVID, new INDs, clinic suits, papers Read More »
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 …
Why did clinic supplier Liveyon halt sales but others kept going despite FDA? Read More »
When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years …
In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex. (update: Stemgenex has since filed for bankruptcy). What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic …
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, …
Clinic biz US Stem (USRM) may be kaput in matter of weeks or months Read More »
If a picture is worth a thousand words, how about a Facebook video from a stem cell clinic? In my view it sure tells a story with some unusual twists. I wrote last week about this Facebook video by Kristin Comella, the leader of the publicly-traded stem cell clinic firm US Stem Cell, Inc. (USRM). As …
Up your nose? OMG Facebook video moments from clinic sued by DOJ Read More »