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!
Common questions
- What did the FDA tell US Stem Cell to do?
- Stop within 15 days. On August 24, 2017 the FDA issued a warning letter to US Stem Cell and Chief Scientific Officer Kristin Comella giving them 15 days to stop using stromal vascular fraction from adipose tissue for multiple medical conditions. The agency stated that making SVF from fat violates at least 3 aspects of current FDA guidelines, making it an unapproved biological drug.
- Should I ask a clinic where their stem cells come from?
- Yes, and it is the single most useful question to ask. If the answer is amniotic fluid, umbilical cord blood, or adipose tissue, particularly stromal vascular fraction, strongly consider a clinic that uses bone marrow instead. Of the sources commonly marketed, bone marrow is the one the FDA has not moved against and the one that meets its criteria as a stem cell source.
- Is fat-derived SVF a stem cell treatment I can get legally?
- Not on the FDA's stated position. The 2017 warning letter set out that stromal vascular fraction made from adipose tissue is a biological drug requiring an approval it does not have. Anyone offered an SVF procedure should ask the clinic directly what FDA approval it holds. Texas Orthobiologics has used bone marrow as its only stem cell source from day one.
