A Practical Guide for the Current Use of Biologic Therapies in Sports Medicine.

Over the past decade, there has been an increased interest in the use of biologic therapies in sports medicine. Although these technologies are in relatively early stages of development, there have been substantial increases in marketing, patient demand, and clinical utilization of biologics, including platelet-rich plasma, bone marrow aspirate concentrate, and other cell-derived therapies. Direct-to-consumer marketing of biologics has also proliferated but is largely unregulated, and clinicians must accurately convey the safety and efficacy profiles of these therapies to patients. Because most insurance companies consider biologic treatments to be experimental or investigational for orthopaedic applications given the lack of high-quality evidence to support their efficacy, patients receiving these treatments often make substantial out-of-pocket payments. With a range of treatment costs among centers offering biologics, there is a need for appropriate and sustainable pricing and reimbursement models. Clinicians utilizing biologics must also have a thorough understanding of the recently clarified Food and Drug Administration guidelines that regulate the clinical use of cell and tissue products. There is a lack of consensus on the optimal preparation, source, delivery method, and dosing of biologic therapies, which has been exacerbated by a lack of sufficient experimental detail in most published studies. Future research must better identify the biologic target of treatment, adhere to better standards of reporting, and better integrate researchers, industry, and regulatory bodies to optimize applications.