SHOULDER ARTHROSCOPY

Q: Are there any updates regarding the use of stem cells in the treatment of rotator cuff tears and other orthopaedic injuries?

A: An excerpt from the October 2019 issue of The Journal of Bone and Joint Surgery, the preeminent journal in orthopaedic surgery, sums up the current state of the art when it comes to stem cell treatments: Many claims for the use of mesenchymal stem cell (MSC) therapy for conditions such as arthritis and tendon disorders lack sound evidence, leading to increasing scrutiny of the efficacy and safety of biologic treatments. There are documented incidents of serious harm to patients after undergoing stem cell treatments in medical tourism destinations and at U.S. clinics using products that violate FDA regulations, including the formation of neoplasms and blindness. In the U.S., there are also reports of bacteremia leading to hospitalization in patients receiving injections of umbilical cord blood products. Infections and other consequences are likely underreported by clinics administering stem cells outside of clinical trials, and the lack of available longitudinal data means that the potential long-term negative effects of treatment are largely unknown. Misleading statements made by MSC therapy clinics abound, and the misconception that clinics operating on false pretenses are predominantly a concern outside the U.S. confounds the reality that hundreds of these clinics exist throughout the country. The potential benefits of MSC therapy for many conditions are not well understood, yet many clinics in the U.S. advertise unsubstantiated benefits of MSC therapy at a cost ranging between $3,000 and $15,000. In response, the Federal Trade Commission has begun investigating these clinics and imposing multimilliondollar penalties for violating truth in advertising laws. MSC therapy clinics must also comply with FDA regulations pertaining to the use and processing of human cells and tissues intended for use in a human recipient to ensure safety, efficacy, and security. The FDA is also investigating MSC therapy clinics and has sought permanent injunctions for the use of products that are not FDA approved and do not comply with good manufacturing practices.

As I have stated in this column previously, research into the effects of stem cell treatments should continue, as we yet do not know whether some of these interventions may in fact help our patients. At the present time, however, consumers should remain highly skeptical of the motivations of practitioners who promote stem cell therapy as a panacea. It may not be the patient who stands to benefit.

To read more about rotator cuff surgery visit ohioshouldercenter.com.

Eric M. Parsons, M.D. Ohio Shoulder Center for Arthroscopy Lake Orthopaedic Associates, Inc. 36060 Euclid Ave., Suite 104 Willoughby 440-942-1050 9500 Mentor Ave., Suite 210 Mentor 440-352-1711 www.ohioshouldercenter.com