Navigating regulatory pathways for translation of biologic cartilage repair products.
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ABSTRACT:
SUBMITTER: Nordberg RC
PROVIDER: S-EPMC9918326 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
Publications
Navigating regulatory pathways for translation of biologic cartilage repair products.
Nordberg Rachel C RC Otarola Gaston A GA Wang Dean D Hu Jerry C JC Athanasiou Kyriacos A KA
Science translational medicine 20220824 659
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 b ...[more]
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