drugset / Trial / NCT00225095
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Phase 1/2
Completed
60 enrolled
Mesoblast, Ltd.
Greater Chesapeake Orthopaedic Associates, LLC · collabMidwest Orthopedics at Rush - Chicago, IL · collabOrthoIndy · collabOrthopedic Center of Vero Beach - Vero Beach, FL · collabTRIA Orthopaedic Center · collabTriangle Orthopaedic Associates, P.A. · collabUniversity of Southern California · collabUnlimited Research - San Antonio, TX · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2005-09
- Primary completion
- 2008-04
- Completion
- 2008-04
Publications
- Background Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143.
- Background Murphy JM, Fink DJ, Hunziker EB, Barry FP. Stem cell therapy in a caprine model of osteoarthritis. Arthritis Rheum. 2003 Dec;48(12):3464-74. doi: 10.1002/art.11365.
- Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | mesenchymal stem cells | Cell therapy | 50 cells | Other |
| Comparator | mesenchymal stem cells | Cell therapy | 150 cells | Other |
| Background | Hyaluronic Acid | Other / unclassified | — | Other |
Indications
No indication recorded.