AMSSM Releases Position Statement on Regenerative Medicine
This position statement provides sports medicine physicians with information on regenerative medicine terminology, a brief review of the basic science and clinical studies, regulatory considerations, and best practices for introducing the orthobiologic classification of regenerative therapies into their clinical practice.The document is being published in the Clinical Journal of Sport Medicine, with accompanying editorial highlights published in the British Journal of Sports Medicine. Both are freely accessible on their respective websites.
“Sports medicine physicians would benefit from decision-making guidance about whether to introduce orthobiologics into their practice and how to do it responsibly,” said Dr. Jonathan Finnoff, the Chief Medical Officer of the United States Olympic and Paralympic Committee and the lead author of the statement. “The information within this statement will help sports medicine physicians make informed and responsible decisions about the role of regenerative medicine and orthobiologics in their practice.”
In 2019, the AMSSM Board of Directors established a Regenerative Medicine Task Force, with a subgroup charged to develop a regenerative medicine position statement. The Task Force brought together a writing group that included sports medicine physicians and scientists who are recognized leaders in bioethics, research, and regenerative medicine clinical applications to produce this statement.
The field of regenerative medicine, and the sub-classification of orthobiologics, involves a variety of therapies and techniques focused on the repair or replacement of damaged or diseased tissue to restore function. Despite these novel therapies being very attractive to sports medicine physicians and patients alike, this is a complex and controversial topic.
“Common orthobiologics that are employed in research and medical practice are being combined under the umbrella of ‘stem cell’ therapy in a manner that is confusing to both patients and the public,” said Dr. Shane Shapiro, one of the lead authors of the statement. “The need for scientifically validated treatments for non-healing orthopedic and sports conditions has increased interest in orthobiologics and other regenerative therapies to address existing treatment gaps.”
The document contains brief discussions of the basic science, proposed therapeutic mechanisms of action, and clinical evidence related to regenerative medicine products, including uses for platelet-rich plasma and other cellular therapies. Additionally, the statement features sections regarding regulatory considerations and an in-depth portion on introducing regenerative medicine into clinical practice.
“Ultimately, this AMSSM position statement on regenerative medicine advocates for the advancement of orthobiologic science, patient safety, and education towards the responsible translation of regenerative therapies,” said Dr. Kenneth Mautner, co-lead author of the position statement and an AMSSM Board member.