Status:
COMPLETED
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Lead Sponsor:
Mesoblast International Sàrl
Collaborating Sponsors:
University of Southern California
Midwest Orthopedics at Rush - Chicago, IL
Conditions:
Recovery Following Partial Medial Meniscectomy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Age 18 to 60, inclusive
- In need of medial meniscectomy
- Normal axial alignment
- Stable knee- previous ligament reconstruction, if stable
- Removal of at least 50% of the affected portion of the medial meniscus
- Intact articular cartilage in posterior meniscal weight-bearing zone
- Willingness to follow normal post-operative rehabilitation
- Willingness to participate in follow-up for two years from the time of meniscectomy surgery
- Ability to understand and willingness to sign consent form
Exclusion
- Pregnant or lactating
- ACL or other support structure damage confirmed at surgery
- Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area \>15mm on weight-bearing aspect of femoral condyle or tibial plateau)
- Synvisc, steroid, or corticosteroid injections in preceding 3 months
- Diffuse synovitis at time of arthroscopy
- Inflammatory arthritis
- Oral steroid, methotrexate therapy
- Unable to follow post-operative exercise regimen or return for evaluations
- Active alcohol or substance abuse within 6 months of study entry
- Current and active tobacco product use
- Patient is positive for HIV
- Patient is positive for hepatitis (past history of Hepatitis A is allowed)
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
- Indwelling pacemaker
- Cerebral aneurysm clips
- Ear, eye and penile implants with avian components
- Electrical indwelling device such as bone stimulator
- Indwelling magnets as tissue expander for future implants
- Known allergy to avian, bovine or porcine protein
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00225095
Start Date
September 1 2005
End Date
April 1 2008
Last Update
December 27 2021
Active Locations (8)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
3
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
4
Ortholndy
Indianapolis, Indiana, United States, 46237