The evolving regulatory landscape in regenerative medicine

Abstract

Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.

Keywords: Extracellular vesicles; Nanomedicine; Regenerative medicine; Stem cells; Translational research.

Figure 1.

The Translational Stages of SC and EV Regenerative Therapies

Figure 2.

The Nine FDA Priority Areas for Advancing Regulatory Science^,

Figure 3.

Regulatory Tiers of HCT/Ps

Figure 4.

Potential Strata for Regulation of Biogenic Nanoparticles