The Use of Biologics in NFL Athletes: An Expert Consensus of NFL Team Physicians

Abstract

Background: There is a lack of published information outlining the use of biologics in National Football League (NFL) athletes and limited data to guide biologic treatment strategies. Purpose: To develop a consensus on the use of biologics among NFL team physicians. Study Design: Consensus statement. Methods: A working group of 6 experts convened a consensus process involving NFL team physicians using validated Delphi methodology. Physicians from 32 NFL teams as well as NFL London were invited to take part. This iterative process was used to define statements on the use of biologics in NFL athletes. A recent scoping review exploring biologics in professional athletes was used to inform the first of 3 rounds of surveys, with statements considered under 7 headings: biologics in general, challenges of treating NFL athletes, terminology/nomenclature, autologous blood products, cell-based therapies, guidance for NFL team physicians, and biologic research in the NFL. In addition to rating agreement, experts were encouraged to propose further items or modifications. Predefined criteria were used to refine item lists after each survey. For a consensus within the final round, defined a priori, items were included in the final information set if a minimum of 75% of respondents agreed and fewer than 10% disagreed. Results: Physicians from 26 NFL teams and NFL London responded to the initial invitation to participate in the Delphi process; 88.9% of participating team physicians completed the round 1 survey, with response rates of 87.5% in round 2 and 95.2% in round 3. After 3 rounds, 47 statements reached a consensus. A consensus was achieved that platelet-rich plasma has a positive impact on patellar tendinopathy and on symptoms in early osteoarthritis but not for other indications. NFL team physicians agreed that while cell therapies have the potential to improve symptoms, the misrepresentation of uncharacterized preparations as “stem cells” has contributed to the widespread use of unproven therapies. Conclusion: This study established an expert consensus on 47 statements relating to the use of biologics in NFL athletes. In addition to providing clinical guidance for the use of biologics in NFL athletes, this study identified key areas for future focus including the development of athlete education materials.

Comparative single-cell transcriptional and proteomic atlas of clinical-grade injectable mesenchymal source tissues

“…Outcomes have been very controversial as some studies suggest promising outcomes while others show no effect. Evidence has been strong enough on both sides so that current consensus statements have not picked a side but say that more studies are needed, and a large body of publications criticize the lack of in-depth characterization of the injected tissue (4,9,(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42). This characterization has, at least theoretically, been made possible when reporting standards for BMAC and adipose preparations were agreed upon in the clinical-translational field (31,37,43), but given the unknown mechanism of action, it has remained challenging to identify a parameter or active ingredient that is predictive of the quality/therapeutic potential of the injectable (34,42).…”

“…These trials then have incorporated measurements of cell yield, such as mononuclear cell counts, CD34 + hematopoietic cells, colony-forming units (CFUs), and in vitro differentiation potential, to define the quality of the injectable (12,19,29,31,37,45). Many clinical experts believe that CFUs and in vitro differentiation are important characteristics of clinical-grade MSCs (31,36,37,(46)(47)(48)(49), and both BMAC and adipose (along with skeletal muscle, cord blood, placenta, periosteum, pancreas, and other tissues) contain cells with those in vitro features (5,7,(50)(51)(52)(53)(54). As a result, they have become some of the most used "stem cell therapies" in patients and athletes (1,2,32,36,40,55) and have even been advertised and used interchangeably (2,3,15,(56)(57)(58) even though there is no rigorous and comprehensive head-to-head comparison of what is in either of them.…”

“…Many clinical experts believe that CFUs and in vitro differentiation are important characteristics of clinical-grade MSCs (31,36,37,(46)(47)(48)(49), and both BMAC and adipose (along with skeletal muscle, cord blood, placenta, periosteum, pancreas, and other tissues) contain cells with those in vitro features (5,7,(50)(51)(52)(53)(54). As a result, they have become some of the most used "stem cell therapies" in patients and athletes (1,2,32,36,40,55) and have even been advertised and used interchangeably (2,3,15,(56)(57)(58) even though there is no rigorous and comprehensive head-to-head comparison of what is in either of them. Knowing this information would allow scientists and clinicians to have some reference standards to start characterizing samples on the basis of ingredients that they think are important.…”