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Highlights from the American Medical Society for Sports Medicine position statement on responsible use of regenerative medicine and orthobiologics in sports medicine
  1. Shane A Shapiro1,
  2. Jonathan T Finnoff2,3,
  3. Tariq M Awan4,
  4. Joanne P Borg-Stein5,
  5. Kimberly G Harmon6,
  6. Daniel C Herman7,
  7. Gerard Malanga8,9,
  8. Zubin Master10,
  9. Kenneth Mautner11
  1. 1Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, Florida, USA
  2. 2Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, USA
  3. 3United States Olympic and Paralympic Committee, Colorado Springs, Colorado, USA
  4. 4Family Medicine and Sports Medicine, AdventHealth, Orlando, Florida, USA
  5. 5Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts, USA
  6. 6Family Medicine, University of Washington School of Medicine, Seattle, Washington, USA
  7. 7Department of Physical Medicine and Rehabilitation, University of California at Davis, Sacramento, California, USA
  8. 8Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA
  9. 9NJ Regenerative Insttitue, Cedar Knolls, New Jersey, USA
  10. 10Biomedical Ethics Research Program and Center for Regenerative Medicine, Mayo Clinic, Rochester, Minnesota, USA
  11. 11Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Georgia, USA
  1. Correspondence to Dr Shane A Shapiro, Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL 32224, USA; shapiro.shane{at}mayo.edu

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Musculoskeletal conditions including osteoarthritis and chronic tendinopathies are leading causes of pain and disability worldwide. The emergence of novel regenerative therapies, referred to as orthobiologics, has led to promising interventions which may reduce pain and improve function. Orthobiologics are biological substances intended to enhance healing and alter the natural course of orthopaedic disease.1 2 Despite growing experience, the field remains under-researched with inconsistent evidence; yet increasing enthusiasm has permitted overexuberant, sometimes inappropriate use with proliferation of misinformation among both providers and patients.

An American Medical Society for Sports Medicine (AMSSM) position statement was developed to help sports medicine physicians make informed and responsible decisions about the role of regenerative medicine in their practice.3 The statement contains relevant terminology, review of basic and clinical science, ethics, regulations and best practices for considering regenerative medicine in clinical practice (figure 1). The statement seeks to educate physicians regarding a broad and emerging discipline and is not an endorsement by AMSSM of any specific product or procedure.

Figure 1

Responsible use of orthobiologics and other novel regenerative therapies requires multiple considerations before translation into routine clinical practice.

Regenerative medicine terminology

Regenerative medicine is rapidly growing with terms and definitions yet to be standardised. While originating with stem cell discovery and translation, regenerative therapies, of which orthobiologics is but one category, are no longer a single platform technology. Rather, they now encompass a heterogeneous collection of biological sources with varying activity that hold the potential to transform human health. Common orthobiologics employed in research and clinical practice are being conflated under the umbrella of ‘stem cell’ therapy in a …

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Footnotes

  • Twitter @ShaneShapiroMD, @DrKimHarmon

  • Contributors We certify that the enclosed manuscript, entitled Highlights from the American Medical Society for Sports Medicine Position Statement on Responsible Use of Regenerative Medicine and Orthobiologics in Sports Medicine, represents original work and that we have reviewed the final version and approve it for publication. Neither this manuscript nor a manuscript with substantially similar content under our authorship has been published or is currently being considered for publication by any other publication. This manuscript will not be submitted to any other publication while it is under consideration by BJSM. We certify that all individuals listed as authors of this manuscript have participated in conceptualising the research or content of the manuscript, in writing or critically editing the manuscript, and/or in analysis of data presented in the manuscript. Each author will complete the ICMJE form to document competing interests related to the subject matter, materials, and products mentioned in this manuscript. A summary of potential competing interest are listed below.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests KM is a Consultant for Lipogems. GM receives Research support and an educational stipend from Lipogems. GM is a Board member of the Interventional Orthobiologic Foundation. JTF is a member of AMSSM Board of Directors, AAPM&R Board of Governors, and the Medical Advisory Board of Sanofi. JTF receives royalties from Demos Publishing and Up to Date. TMA is a consultant Consultant for Arthrex and Fujifilm Sonosite. TMA receives research funding from InGeneron, GID-BioMiMedx, Flexion Therepeutics, and Endo Pharmaceuticals. SAS is a consultant for Bioventus and on the BOD of the Biologic Association.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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