Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy

A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years

The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).

The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.

Inclusion Criteria:

• Subject must have received an injection in Protocol No. 550
• Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
• Subject must provide written informed consent for entry into the extension study
• Subject must provide authorization for use and disclosure of protected health information for entry into the extension study