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Phase III clinical trials begin for stem cell-based cartilage regeneration therapy



Researchers at Osaka University have developed a synthetic tissue for treating damaged cartilage, which had previously been incurable and had no effective therapies. Their method uses synovium-derived mesenchymal stem cells (MSCs) as the starting material.

In a Phase III clinical study to confirm the efficacy and safety of this therapy, surgery was successfully performed on the first patient. This is the first clinical trial of regenerative therapy in Japan using allogeneic stem cells and the commercial use of a stem cell bank at the Medical Center for Translational Research (MTR) of Osaka University. (In 2015, MTR established a stem cell bank to provide high-quality homologous cells for a consistent process from basic research to clinical application and commercialization.)

Articular cartilage does not have blood supply and, thus, has limited ability to heal itself. To date, there are no effective treatment methods. Therapies using stem cells and tissue engineered techniques are being developed throughout the world; however, it has been difficult to attain good regenerative repair quality and good tissue integration-to-lesion base.

By combining monolayer culture and suspension culture, Nakamura Norimasa, M.D., Ph.D., Hideki Yoshikawa, M.D., Ph.D., and Yoshiki Sawa, M.D., at Osaka University developed three-dimensional synthetic tissue with excellent differentiation ability and tissue adhesive properties, using only MSCs as the starting material. These unique properties have enabled transplantation by minimally invasive approaches such as arthroscopy.

In this clinical trial, allogeneic culture is performed in a serum-free culture medium. This meant that only one operation was required, in contrast with conventional autologous implantation that requires two operations to accomplish the treatment, which both reduces the burden on patients and is more cost effective.

Scaffold-free tissue engineered construct derived from synovial mesenchymal stem cells. Image courtesy of Osaka University


Cartilage repair by the TEC (Phase I/II trial). Top left: before implantation. Bottom left: one year post surgery; Right: histology. Image courtesy of Osaka University.

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