In-vitro cultured chondrocyte containing products for cartilage repair of the knee - Scientific guideline

This document addresses specific points related to medicinal products containing in vitro cultured autologous chondrocytes intended for the repair of cartilage lesions of the knee. It supplements the guideline on human cell-based medicinal products.

Keywords: Chondrocytes, cell therapy, autologous, advanced therapies, cartilage repair, quality, non-clinical, clinical

Current effective version

Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee

Adopted Reference Number: EMA/CAT/CPWP/568181/2009 Summary:

This reflection paper addresses specific points related to medicinal products containing in vitro cultured autologous chondrocytes intended for the repair of cartilage lesions of the knee. This reflection paper is considered to supplement the ‘Guideline on human cell-based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline.

Document history - First version (current)

Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee

Adopted Reference Number: EMA/CAT/CPWP/568181/2009 Summary:

This reflection paper addresses specific points related to medicinal products containing in vitro cultured autologous chondrocytes intended for the repair of cartilage lesions of the knee. This reflection paper is considered to supplement the ‘Guideline on human cell-based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline.

Overview of comments received on 'Reflection paper on In-Vitro cultured chondrocyte containing products for cartilage repair of the knee’ (EMA/CAT/568181/2009)

Reference Number: EMA/CAT/65294/2010

Draft reflection paper on in-vitro cultured Chondrocyte containing products for cartilage repair of the knee

Draft: consultation closed Consultation dates: 11/09/2009 to 31/12/2009 Reference Number: EMEA/CAT/CPWP/288934/2009