NCT00225095

A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy

A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years

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

Summary

The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).

Detailed description

Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year. Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.

Conditions

• Recovery Following Partial Medial Meniscectomy

Interventions

Type	Name	Description
DRUG	Mesenchymal Stem Cells
DRUG	Hyaluronan

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-23
• Last updated: 2021-12-27

Locations

8 sites across 1 country: United States