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Collagen Scaffold for Cartilage Repair approved for marketing

CCFDIE|Updated: 2023-04-04

     

Recently, the innovative product Collagen Scaffold for Cartilage Repair (COLTRIX CartiRegen) of Ubiosis Co., Ltd is approved by China NMPA.

This product innovatively adopts the process sterilization during collagen extraction in manufacturing, and removes the immunogenic terminal peptide structure, which enables steady batch production of collagen materials with a complete triple helix structure.

This product is mainly composed of collagen, which serves as a biological scaffold to provide space for cell adhesion, proliferation, and migration of autologous bone marrow mesenchymal stem cells (BMSCs). After the implantation of collagen scaffold for cartilage repair, the chondrocytes could be differentiated from BMSCs and migrated and proliferated in surrounding healthy cartilage tissue. Chondrocytes continuously synthesize and secrete type II collagen, forming new cartilage tissue and further repairing damaged cartilage. During this process, the collagen scaffold gradually degrades, and the degradation products can be absorbed by chondrocytes as nutrients or excreted from the body through metabolism.

The existing techniques for repairing cartilage injuries commonly include microfracture surgery, cartilage transplantation, chondrocyte transplantation, and joint replacement. The collagen scaffold for cartilage repair applied in conjunction with knee microfracture surgery is expected to benefit more patients as the marketing of this product.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.