Until recently, Bone Marrow and Adipose (fat) were the only methods being used to harvest stem cells. But recent discoveries have shown that Umbilical Cord Tissue provides much higher concentration of Mesenchymal Stem Cells for a lower cost, with a less invasive procedure and lower risk to the patient. Plus umbilical Cord tissue is harvested from healthy umbilical cords that previously would have been discarded as medical waste. Umbilical cord tissue from young mothers provides healthier and more viable stem cells than those of a 60 year old, who is the patient.
Reasons Not to Use Bone Marrow or Adipose Stem Cells
Protocols that utilize a bone marrow or adipose tissue extraction typically costs more per unit and is more risky because it requires surgery and anesthesia. Bone marrow extraction requires drilling into the patient’s pelvis, thigh or heel bones and adipose tissue extraction requires liposuction. Because of the trauma that both of these harvesting procedures cause to the patient, most patients are usually only given one treatment, eventhough they really need two or three.
Although Bone marrow aspiraton provides much lower quantities of stem cells than umbilical cord tissue, it has been considered the gold standard and has yielded thousands of positive results. Adipose tissue does contain stem cells, but the FDA has recently ruled that it cannot be legally administered for treating arthritis or other joint conditions because it does not meet FDA guidelines, which require the stem cell source tissue to have the same or similar function as the target tissue. The FDA calls this “homologous use.” Additionally, adipose tissue requires more than minimal processing to separate the stem cells and prepare them for injection, therefore, it also does not meet the FDA “minimally manipulated” requirement.
In early 2018, the FDA sent a warning letter to American CryoStem, a company involved in processing and distributing adipose stem cells to doctors. In the FDA Warning letter to the company and the accompanying FDA press release (PR), the FDA stated that the company’s adipose stem cell product ATCELL™ is not minimally manipulated and that its administration did not qualify as homologous use. For these reasons, the letter said that ATCELL™ is a drug product, but the company does not have an IND (Investigational New Drug) or other required drug approval.
In the bigger picture, the FDA’s recent final guidances and oversight actions paint a consistent picture that adipose stem cells, most commonly referred to as stromal vascular fraction, are biological drugs requiring FDA pre-market approval.