FDA Regulation of Adult Stem Cell Therapies as Used in Sports Medicine

Mary Ann Chirba; Berkley Sweetapple; Charles P. Hannon; John A. Anderson

doi:10.1055/s-0034-1398470

The Journal of Knee Surgery, Table of Contents

J Knee Surg 2015; 28(01): 055-062
DOI: 10.1055/s-0034-1398470

Special Focus Section

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

FDA Regulation of Adult Stem Cell Therapies as Used in Sports Medicine

Mary Ann Chirba

¹Boston College Law School, Newton Centre, Massachusetts

,

Berkley Sweetapple

¹Boston College Law School, Newton Centre, Massachusetts

,

Charles P. Hannon

²Georgetown University School of Medicine, Washington, District of Columbia

,

John A. Anderson

³Department of Sports Medicine, Rothman Institute, Philadelphia, Pennsylvania

› Author Affiliations

Abstract

In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its “Human Cells, Tissues, and Cellular and Tissue-Based Products” regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.

Keywords

mesenchymal stem cells - adipose stem cells - HCT/Ps - FDA Section 361 - FDA Section 351 - minimal manipulation - sports medicine - cartilage - ACL - meniscus

Full Text

References

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