Ethical and Regulatory Considerations Related to Regenerative Medicine.

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

The possibility of modifying disease through regenerative medicine applications, particularly stem cell therapies, raises ethical and regulatory challenges in orthopedics. This review article provides historical context of stem cell research, ethical issues such as informed consent, therapeutic misconception, and equitable access, emphasizing the responsibilities of providers offering investigational treatments. It also examines the evolving role of the U.S. Food and Drug Administration (FDA) in regulating regenerative therapies through frameworks like the Regenerative Medicine Advanced Therapy (RMAT) designation, and more point-of-care enforcement discretion policies for therapies such as autologous micro-fragmented adipose tissue and bone marrow aspirate concentrate. The authors underscore the importance of innovative therapies to address unmet needs in musculoskeletal healthcare while acknowledging the need for more rigorous basic and clinical research. They call for a continuous refinement of regulatory and ethical standards as regenerative medicine advances.

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

Browse all related research

Filter the research library by this study's title keywords, author, or publication year.