ASCTA was formed in response to the FDA’s position that the patient’s own stem cells are considered drugs (unlike Wharton’s Jelly and Exosomes) and should be regulated as such. Strong opposition by physicians and patients worldwide motivated the effort to research and publish scientific guidelines that provide the medical community with standards under which adult stem cell therapy can be practiced safely. These stem cell therapy guidelines represent the world’s first clinical guidelines designed to facilitate safe stem cell therapy practice. A key aspect of the document is the concept that adult stem cell therapy with the patient’s own cells is governed under the practice of medicine, not under drug production guidelines.