Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Aug 30:15563316251361511.
doi: 10.1177/15563316251361511. Online ahead of print.

Ethical and Regulatory Considerations Related to Regenerative Medicine

Prathap Jayaram  1   2 , Richard M Danilkowicz  1 , Xiaoning Yuan  3
Affiliations
Review

Ethical and Regulatory Considerations Related to Regenerative Medicine

Prathap Jayaram et al. HSS J. .

Abstract

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.

Keywords: clinical trials; ethics; orthobiologics; regenerative medicine; stem cells.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Prathap Jayaram, MD, declares no potential conflicts of interest. Richard M. Danilkowicz, MD, reports relationships with AANA and Enovis. Xiaoning Yuan, MD, PhD, reports relationships with AAOS, AR3T, ASMST, ASSM, DOD, DHA, MAST, MTEC.

References

    1. Jayaram P, Ikpeama U, Rothenberg JB, et al. Bone marrow–derived and adipose-derived mesenchymal stem cell therapy in primary knee osteoarthritis: a narrative review. PM&R. 2019;11:177–191. - PubMed
    1. Whittle SL, Johnston RV, McDonald S, et al. Stem cell injections for osteoarthritis of the knee. Cochrane Database Syst Rev. 2025;4:CD013342. - PMC - PubMed
    1. Zhidu S, Ying T, Rui J, Chao Z. Translational potential of mesenchymal stem cells in regenerative therapies for human diseases: challenges and opportunities. Stem Cell Res Ther. 2024;15:266. - PMC - PubMed
    1. Sharkis SJ. Canadian stem cell scientists take the prize. Cell. 2005;122:817–819. - PubMed
    1. Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991;9:641–650. - PubMed

LinkOut - more resources