A History of Firsts
- Genzyme manufactures and commercializes CARTICEL, the first and only cell-based therapy for cartilage repair.
- First patient is treated with CARTICEL in the U.S.
- Viability assay implemented.
- CARTICEL biologics license application (BLA) is filed.
- CARTICEL receives approval in accordance with new FDA cell therapy guidance.
- It is the first, FDA-approved, biologics license application for cell therapy.
- CARTICEL is the only autologous cultured chondrocyte product available in the U.S.
- First rapid automated sterility test for lot release of a biologic.
- The Study of the treatment of articular repair, first Good Clinical Practice (GCP) study in the U.S. for cartilage repair completed.
- Identity assay FDA-approved and implemented as part of the final release criteria for each patient lot.
Ready to proceed with CARTICEL? You’re already on the right path.
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