In March, the Pain Physician Journal published a position statement from the American Society of Interventional Pain Physicians (ASIPP). TOBI faculty, Dr. Christopher Centeno, and other contributing authors hope this review will aid regulators overseeing regenerative musculoskeletal medicine. Their objective being to provide a comprehensive, focused, review of literature describing the current regulatory guidelines and definition of “homologous use,” ASIPP shows that bone marrow concentrate (BMC) meets such criteria.
Statement 1: Based on a review of literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption.
Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions.
The evidence is highest for knee osteoarthritis with level II (Moderate) evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies.
Based on the relevant systematic reviews, randomized trials, and nonrandomized controlled trials, the evidence for disc injections is level lll (Fair).
Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections.
Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique.
Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements of promising new therapies into clinical evaluation and use.
Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use.
Statement 6: Development of cell based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes have putative potential, and this has led the FDA and the Federal Trade Commission (FTC) to issue multiple warnings. Thus, the US FDA is considering the appropriateness of various therapies, including BMC, for homologous use.
Statement 7: Since the 1980s, … the use of BMC in musculoskeletal and spinal disorders has increased in the management of pain and promoting tissue healing.
Statement 8: The Public Health Service Act (PHSA) requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is proven by preclinical and clinical evidence.
Statement 9: If the FDA does not accept BMC as homologous, then BMC injections will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use.
Statement 10: Based on the literature review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.
Public awareness that biologics have therapeutic value for treating musculoskeletal disorders and painful, degenerative conditions has been acknowledged and publicized in the open forum of professional athletics. In doing so, orthobiologic techniques have merged with other cosmetic and health industries, and their applications have jeopardized legitimacy and safety. Thereby, with intent to protect consumer safety, the FDA seeks to deliberate on the application of BMC injections as homologous use and with minimal manipulation. BMC is currently covered under the 21 CFR 1271.15(b) same surgical exemption, requiring that the cells are extracted and reintroduced into the same patient during the same procedure.
Musculoskeletal disorders are the leading contributing factors of disability in the US. Economic projections show that health care expenditures will continue to increase annually at a rate of 5.5% from present day through 2027. Consequently, musculoskeletal disorders add a tremendous burden to our health care system and substantially contributes to physical disability with a reduced quality of life. Moreover, opioid use has become a national epidemic in the US concerning drug-related deaths as a consequence of pain and physical disability. Professionals trained and skilled in the application of BMC to treat musculoskeletal and spinal conditions agree that this modality is effective in treating pain and disability.
These position statements consider the impact of musculoskeletal and spine disorders on health care costs, the opioid epidemic, and disability; evidence of minimal manipulation and homologous use based on MSCs and growth factors of BMC for multiple musculoskeletal structures including the disc; effectiveness and safety; and finally the evidence to show BMC in musculoskeletal disorders meet the criteria of minimal manipulation and homologous use.
Numerous TOBI Faculty and alumni collectively authored these position statements alongside other physicians and researchers. Access the full article here. Be sure to join us for the TOBI 2021, June 10-12, 2021, for an update on Regulatory Standards and Compliance in Orthobiologics. Know how to market your services while managing your risk. Pre-register now!