As President of the Interventional Orthopedic Foundation, it was with great interest that I read the article by Denise Grady and Reed Abelson: “An Unproven Cure”. This article notes that “stem cell treatments have risen, despite little evidence they work” and goes on to note that “rogue clinics are accused of doing harm.” Unfortunately, the authors failed to provide the numerous scientific articles that have demonstrated significant safety of various OrthoBiologic treatments such as platelet rich plasma and bone therapies treatment for various orthopedic conditions. There is now a large body of evidence noting the significant safety of these treatments. In addition, there is a large body of evidence demonstrating the efficacy of platelet rich plasma for chronic lateral epicondylosis I.e. tennis elbow as well as mild to moderate knee osteoarthritis. 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. Unfortunately, this scientific evidence of efficacy has been hijacked by unscrupulous clinicians using less than adequate technique with a few 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 and adverse events. It is therefore critical that any treatment in particular new and innovative treatments are performed with appropriate training, standards and guidelines. Interventional Orthopedic Foundation is dedicated to this important aspect of training in the area of OrthoBiologic treatments.

The authors also failed to document the significant lack of evidence for up to 80% of current orthopedic procedures. While these procedures continue to be performed and paid for by insurance carriers, there are several procedures that have now been shown to be without appropriate evidence versus other treatments including placebo treatment i.e. arthroscopic partial meniscectomy for meniscal tears. The authors briefly mention the concerns regarding total knee replacement but failed to note that 30% of patients undergo total knee replacement have ongoing knee pain. In addition, there are numerous potential complications related to various surgical interventions ranging from infection, nerve injury, blood clots and even death.

Ultimately, appropriate data regarding outcomes is desperately needed in all areas of medicine and specifically in this new area of OrthoBiologic treatments for orthopedic conditions. As President of the Interventional Orthopedic Foundation, one of my missions will be to establish a national registry database which will be available to clinicians across the country and worldwide at extremely low cost and minimal interruption of their practice which are hurdles that prevent data collection at this time. With this real-world data, the various treatments can be more closely examined and the outcomes can be made available to both clinicians and patients. It is my recommendation that any center or clinic that offers these types of treatments be mandated to collect safety outcome data on all their patients in a national registry database. This may be something for the FDA to consider as it tries to regulate this difficult to control area of medical treatments.

Innovations in medicine are always met with great skepticism and often with great criticism. This dates back to even the concept of hand-washing by Lister prior to the treatment of women in labor and surgery. Stem cell treatments offer a great potential option for patients suffering from various orthopedic conditions but this potential must be proven through the collection of data. In addition, these treatments should be provided to patients using the highest level of techniques through appropriate training and the establishment of standards and guidelines. Clinicians interested in using the highest level of techniques and in collecting the outcomes of these treatments through a national registry database should be supported while ferreting out those who wish to only take advantage of the science that is available using nonstandardized techniques and slick marketing. Ultimately, treatments that are in the best interest of the patient will be offered and provided in the best available techniques.

Gerard A Malanga, MD
President of the Interventional Orthopedic Foundation

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