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
adipose stem cells
The cost of stem cell treatments is a big deal for many reasons including the burden it puts on patients, who often then turn to friends, family and even the Internet to try to obtain the money needed to pay the for-profit clinic. A reasonable question to ask is how the cost of a stem cell treatment compares to the costs of more standard of care options. Most often clinic stem cell offerings are more expensive, but not always. However, “value” is another consideration …Read More
Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America. Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in …Read More
The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning letter and in an accompanying press release (PR) that ATCELL™ is not minimally manipulated and that its administration did not qualify as homologous use. For these reasons, the letter …Read More