FDA clearly states that umbilical cord blood is NOT exempt from registering as a biologics drug under section 351.
FDA states that “….using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).”
Ok, just kidding, FDA doesn’t endorse any stem cell sources….BUT the FDA doesn’t regulate bone marrow as a stem cell source when used in orthopedics and they DO regulate adipose(fat), amniotic fluid, umbilical cord blood, placental tissues, and other stem cell sources used in orthopedics as biologic drugs. So, stick with the one source that is given the “top-line” exemption for use by the FDA. Here is a 15 minute video on why the FDA doesn’t regulate bone marrow in orthopedics.
These clinics and providers that are being sued all have a few things in common…..
#1 they all use either adipose or blood as a supposed source of stem cells
Dr. Joel Singer is a plastic surgeon affiliated with the Cell Surgical Network, who has publicly announced he has treated NFL player(s) with IV adipose tissue for concussions or other neurologic disorders. According to the FDA guidelines, adipose tissue digested to make SVF or made into smaller adipose tissue pieces broken down by mechanical disruption is a biologic drug. Biologic drugs need to be registered and go thru a well defined and expensive and time consuming FDA process BEFORE being approved for human use. Dr. Singer doesn’t have an Investigational Drug License or a BLA on file with the FDA so apparently, according to the FDA…he is using and promoting an unapproved biologic drug.
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.
