A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years
Overview
- Phase
- Phase 1
- Intervention
- Mesenchymal Stem Cells
- Conditions
- Recovery Following Partial Medial Meniscectomy
- Sponsor
- Mesoblast International Sàrl
- Enrollment
- 60
- Locations
- 8
- Primary Endpoint
- Meniscal Volume
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year. Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Chondrogen - dose 1
Chondrogen - 50 million cells
Intervention: Mesenchymal Stem Cells
Chondrogen - dose 2
Chondrogen - 150 million cells
Intervention: Mesenchymal Stem Cells
Vehicle Control
Vehicle Control
Intervention: Hyaluronan
Outcomes
Primary Outcomes
Meniscal Volume
Time Frame: 6 months
Changes in meniscal volume over the course of the study as determined by MRI
Secondary Outcomes
- Lysholm Knee Scale(2 years)
- Safety Assessment Adverse Event(2 years)
- Safety Assessment Immunological(2 years)
- Safety Assessment Laboratory(2 years)
- Quality of Life Questionnaire(2 years)
- Visual Analog Scale (VAS)(Baseline to 2 years)
- Safety Assessment Physical Exam(2 years)
- Safety Assessment Magnetic Resonance Imaging (MRI)(2 years)