Navigating regulatory pathways for translation of biologic cartilage repair products

Sci Transl Med. 2022 Aug 24;14(659):eabp8163. doi: 10.1126/scitranslmed.abp8163. Epub 2022 Aug 24.

Abstract

Long-term clinical repair of articular cartilage remains elusive despite advances in cartilage tissue engineering. Only one cartilage repair therapy classified as a "cellular and gene therapy product" has obtained Food and Drug Administration (FDA) approval within the past decade although more than 200 large animal cartilage repair studies were published. Here, we identify the challenges impeding translation of strategies and technologies for cell-based cartilage repair, such as the disconnect between university funding and regulatory requirements. Understanding the barriers to translation and developing solutions to address them will be critical for advancing cell therapy products for cartilage repair to clinical use.

Publication types

  • Review
  • Research Support, N.I.H., Extramural

MeSH terms

  • Animals
  • Biological Products*
  • Cartilage, Articular*
  • Cell- and Tissue-Based Therapy
  • Humans
  • Tissue Engineering
  • United States
  • United States Food and Drug Administration

Substances

  • Biological Products