Today the FDA issued a warning letter (http://bit.ly/fdausstemcell) to US Stem Cell and their Chief Scientific Officer, Kristin Comella, giving them 15 days to stop their current practice of using stromal vascular fraction (adipose tissue) for multiple medical conditions. The FDA was very clear in its position statement that it considers making SVF from adipose tissue to be a violation of at least 3 aspects of the current FDA guidelines and therefore is considering making a biological drug….which is not approved by the FDA. Be sure to ask the source of stem cells if you see a clinician for consultation! If they say they are using amniotic fluid or umbilical cord blood or adipose tissue (especially SVF) you should strongly consider seeing a clinic that uses bone marrow instead…..since this is the one source of those mentioned that is not being shut down by the FDA and meets all of their criteria as a stem cell source. We have only used bone marrow as our stem cell source from day 1!
FDA issues warning letter to US Stem Cell/Kristin Comella Over Advertising and Using Adipose SVF for Stem Cells
Posted in: Legal Issues With Regenerative Medicine (USA) | Posted on: 24 August, 2017