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

Phase 1

Completed

• Conditions: Recovery Following Partial Medial Meniscectomy
• Interventions: Drug: Chondrogen; Drug: Placebo

• Registration Number: NCT00702741
• Lead Sponsor: Mesoblast International Sàrl

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2021-12-23
• Status Verified: 2022-01
• Disposition First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Disposition First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Chondrogen	Chondrogen (low dose)
B	Chondrogen	Chondrogen (high dose)
C	Placebo	Hyaluronan

Primary Outcome Measures

Name	Time	Method
Comparison of treatment adverse event rates	Through 3 years

Secondary Outcome Measures

Name	Time	Method
Concomitant Medications	Through 3 years
Visual Analog Scale	Through 3 years

Trial Locations

Locations (4)

TRIA Orthopaedic Center; 🇺🇸 Bloomington, Minnesota, United States

University of Southern California Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Unlimited Research; 🇺🇸 San Antonio, Texas, United States

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States