A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years
Overview
- Phase
- Phase 1
- Intervention
- Chondrogen
- Conditions
- Recovery Following Partial Medial Meniscectomy
- Sponsor
- Mesoblast International Sàrl
- Enrollment
- 55
- Locations
- 4
- Primary Endpoint
- Comparison of treatment adverse event rates
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Chondrogen (low dose)
Intervention: Chondrogen
B
Chondrogen (high dose)
Intervention: Chondrogen
C
Hyaluronan
Intervention: Placebo
Outcomes
Primary Outcomes
Comparison of treatment adverse event rates
Time Frame: Through 3 years
Secondary Outcomes
- Concomitant Medications(Through 3 years)
- Visual Analog Scale(Through 3 years)