NCT00702741

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mesoblast International Sàrl · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Recovery Following Partial Medial Meniscectomy

Interventions

Type	Name	Description
DRUG	Chondrogen	Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
DRUG	Chondrogen	Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
DRUG	Placebo	Intra-articular injection of Hyaluronan

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-06-20
• Last updated: 2022-01-11

Locations

4 sites across 1 country: United States