The June edition of the Journal of the American Medical Association (JAMA) featured a research letter investigating the characteristics and scope of training of clinicians offering stem cell treatments in the U.S.. The findings of the investigation were troubling, yet not surprising, indicating that many clinicians are providing stem cell treatments for conditions outside of the scope of their training. You can read the full article at this link.
The Interventional Orthopedics Foundation (IOF) is dedicated to pioneering and developing the medical sub-specialty of Interventional Orthopedic Medicine by collaborating across medical specialties and bringing together the physicians who are doing the right thing with regenerative medicine. We recognize that achieving this mission requires regulations be put in place to ensure patient safety, including policies that verify stem cell therapies are only being provided by properly trained and licensed clinicians. Accordingly, IOF is advocating for the creation of a standardized registry and educational curriculum to guide our members on the pathway to becoming an orthobiologics expert.
IOF President Dr. Gerard Malanga submitted a letter to the editor in response to the research letter published in JAMA to share the organization’s perspective with the medical community . The JAMA editorial staff declined to publish the letter. Please see the full letter below.
It was with great interest that I read the Research Letter published by Fu et all in the recent JAMA Journal (1). I currently serve as the President of the Interventional Orthopedic Foundation (IOF), a nonprofit organization dedicated to educating physicians and developing standards and guidelines for the use of orthobiologics to treat orthopedic conditions. IOF shares the concerns raised in this article regarding clinicians practicing beyond their scope of training and agrees that this practice has become prevalent, increasing risks to patients.
The term “stem cell interventions” is quite vague and often used by various centers providing treatments that do not actually contain any type of “stem cells”. IOF recommends procedures be defined to ensure consumers are able to discern which clinicians are offering legitimate treatments. The authors of this report continually describe stem cell therapies as an unproven treatment. While additional research is necessary, to date, the majority of research regarding bone marrow mesenchymal stem cell treatments for knee osteoarthritis in particular has been very positive with an excellent safety profile. Unfortunately, this scientific evidence of efficacy has been hijacked by unscrupulous clinicians using less than adequate and unstandardized technique, with a few of these centers providing treatment that amounts to medical malpractice.
As in any area of medicine, treatments that are improperly performed without attention to standards and guidelines will result in the potential for serious complications. It is therefore critical that any treatment, in particular new and innovative treatment, is performed with appropriate training, standards and guidelines. IOF is advocating for the creation of a standardized national registry database to ensure clinicians using the highest level of techniques are able to collect the outcomes of these treatments and establish their efficacy. A national registry will empower clinicians using research-based techniques while dissuading those who wish to take advantage of vulnerable patient populations by using non-standardized techniques and slick marketing to sell procedures that are ineffective at best and deadly at worst.
Ultimately, treatments that are in the best interest of the patient will be offered and provided using the best available techniques.
Gerard A. Malanga, MD
President, Interventional Orthopedic Foundation (IOF)
1. Wayne Fu, MD, MBA; Cambray Smith, BS; Leigh Turner, PhD3: et alCharacteristics and Scope of Training of Clinicians Participating in the US Direct-to-Consumer Marketplace for Unproven Stem Cell Interventions. JAMA. 2019;321(24):2463-2464. doi:10.1001/jama.2019.5837.
2. L Stefan Lohmander, Ewa M Roos The evidence base for orthopaedics and sports Medicine Scandalously poor in partsBMJ 2014;350:g7835 doi: 10.1136/bmj.g7835 (Published 2 January 2015)
3. Katz JN, Brophy RH, Chaisson CE, et al. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med 2013; 368(18):1675-1684.
4. Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013; 369(26):2515-2524