Status:
COMPLETED
Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
Lead Sponsor:
Mesoblast International Sàrl
Conditions:
Recovery Following Partial Medial Meniscectomy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00702741
Start Date
June 1 2008
End Date
September 1 2011
Last Update
January 11 2022
Active Locations (4)
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1
University of Southern California Keck School of Medicine
Los Angeles, California, United States
2
OrthoIndy
Indianapolis, Indiana, United States
3
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
4
Unlimited Research
San Antonio, Texas, United States