Table 4. . Assurance of cell quality, US FDA regulation, safety claims, clinical benefits and adverse/side effects.

Theme/example quotes	Businesses (n)
The business mentioned FDA regulation of the marketed intervention and/or assurance of cell quality either during presentation or on own website: – “While stem cell therapy is overseen and regulated by the FDA it is NOT completely FDA approved. It’s speculated that stem cell therapy will be FDA approved in time, but as of now it’s only regulated by the FDA. Stem cell therapy is 100% legal to practice in the United States as long as the stem cells are gathered from a legal source, and the clinic administering the therapy follows proper medical procedures.” – “FDA allows for minimal manipulation [12] to happen during the transplantation phase.” – “The FDA does not approve nor disapprove natural treatments. They approve food, drugs, and medical procedures. The FDA does regulate how these cells are housed and processed.”	5
The business mentioned adverse/side effects of the marketed intervention: – “Small percentage of patients experience flu-like symptoms that last no longer than 24–48 hours. I personally never had that happen in my clinic, but that the lab does say that.” – “There may be mild soreness in the joint for up to a week after the procedure. Heavy exertion should be avoided during this period.” – “Patients experience minimal discomfort during the procedure, it’s a small injection that they can actually get up and walk out of the appointment that same days. There’s no sedation and no down time and the symptoms can begin to improve within 1 to 2 months of the treatment.”	7
The business mentioned clinical benefits obtained by the marketed intervention: – “The patch duplicates young stem cells and deploys existing stem cells through epigenetics which works with our internal organs.” – “15% see results within 24 hours. 60% see results by 8 weeks. Most of the tissue growth occurs from 3 to 8 months. Improvements can take up to one year.” – “Patients typically have 30% to 50% improvement from baseline.”	8
The business made safety claims for the marketed intervention: – “Stem cell therapy does not alter the DNA of other cells. Only carcinogens and viruses are able to negatively alter the DNA.” – “Stem cells hold the promise of treatment and cures far more than 70 major diseases that affect millions of people.” – “There’s no safety concerns or adverse effects that we've seen … I’ve never seen a rejection. I’ve never seen allergic reaction from them so they’re safe.”	7