June 4, 2020

The Niche

Knoepfler lab stem cell blog

Stromal Vascular Fraction

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

5 min read

When people discuss “fat stem cells” they usually mean something called “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 and I’ve updated this post in May 2020. What exactly is Stromal Vascular Fraction (SVF)? In a nutshell, stromal vascular fraction is a cellular extract made …Read More

5 min read

It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). There is a wide range of opinions on the long-term meaning of this court ruling. Some like me view it as likely making a major positive difference, while others …Read More

3 min read

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …Read More

4 min read

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney …Read More

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More