In one of the first studies of its kind, Mayo Clinic analyzed a large group of patients to understand their motivations for seeking stem cell therapies and whether expectations are grounded in science. The findings could help health care professionals cut through misleading claims and better counsel patients. This research by Jennifer Arthurs; Zubin Master, Ph.D.; and Shane Shapiro, M.D. — all of Mayo Clinic —¸is published in NPJ Regenerative Medicine.

"We learned that many patients interested in stem cells had beliefs that are not supported by current medical evidence. For example, many thought stem cells were better than surgery or standard of care," says Dr. Master, a bioethicist in Mayo Clinic's Center for Regenerative Medicine and co-senior author.

Stem cell therapies are not approved for routine clinical care. Therefore, they are not covered by insurance. Mayo Clinic is one of the first to offer a Regenerative Medicine Consult Service to inform patients and responsibly advance regenerative therapies. The consult service educates patients about the facts of stem cell and orthobiologic therapies.

"Findings of this study reinforce the value of Mayo Clinic's Regenerative Medicine Consult Service. Patients remain interested in stem cell therapy, but many may be misinformed about the efficacy of these treatments," says Arthurs, a nurse practitioner and patient coordinator in the Regenerative Medicine Therapeutics Suites at Mayo Clinic in Florida. "Mayo Clinic can serve as a trusted source of health information about regenerative care."

Mayo Clinic's Center for Regenerative Medicine supports the Regenerative Medicine Therapeutic Suites as part of its objective of advancing the practice in alignment with Mayo's 2030 vision.

The research

The research team analyzed 533 people, the largest known sampling of patients seeking stem cell and other regenerative therapies for musculoskeletal conditions — often called orthobiologics. The patients surveyed were considering a consultation at the Regenerative Medicine Therapeutic Suites between November 2018 and February 2020, and they had a median age of 68. Half were female.

They were asked three questions:

• Why are you interested in stem cell treatment for your condition?
• How did you find out about stem cell treatment for your condition?
• Have you contacted a stem cell clinic?

Approximately 27% said they thought stem cell therapies would delay or avoid joint replacement surgery; 26% said they thought it would ease pain; and nearly 19% thought stem cell injections would be a better or less invasive option than surgery.

"Clinical evidence does not suggest that joint replacement or tendon repair is fully avoidable or that stem cell therapy is better than standard of care or surgical options," says Dr. Shapiro, medical director of the Regenerative Medicine Therapeutic Suites and co-senior author of the study.

The most common source of information respondents cited was online internet searches, followed by word-of-mouth recommendation from family or friends.

"Understanding patients' health knowledge and intentions when considering orthobiologics and stem cell therapy is crucial to help patients navigate the various clinical options appropriate for their care needs," says Arthurs.

The analysis revealed that many of the patients had contacted a stem cell clinic before seeking consultation at Mayo Clinic. However, those who were willing to have an in-person consultation were less likely to have contacted a stem cell clinic and more likely to have been referred to Mayo by a health care professional.

Most surprising to the research team is that many patients had not heard about stem cell procedures from the ClinicalTrials.gov website, where stem cell clinics often present their services as pay-to-participate experimental research.

"Our data suggest that policies to increase oversight of the ClinicalTrials.gov site may not serve to actually inform patients that some of the listed studies in the registry are not actual research studies but are misleading claims by stem cell clinics," says Dr. Master.

The study team concludes that health care professionals interested in advancing responsible stem cell and orthobiologic therapies should, like the Regenerative Medicine Consult Service, make efforts to consult patients on their different options, provide factual information and correct misunderstandings while respecting patient motivations for seeking such therapies.

Because this research is mainly among patients seeking stem cell therapies for musculoskeletal conditions, the team recommends further studies to reflect the attitudes of a wider population interested in orthobiologic and stem cell therapies.
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