A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
- Conditions
- Recovery Following Partial Medial Meniscectomy
- Interventions
- Registration Number
- NCT00225095
- Lead Sponsor
- Mesoblast International Sàrl
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chondrogen - dose 2 Mesenchymal Stem Cells Chondrogen - 150 million cells Chondrogen - dose 1 Mesenchymal Stem Cells Chondrogen - 50 million cells Vehicle Control Hyaluronan Vehicle Control
- Primary Outcome Measures
Name Time Method Meniscal Volume 6 months Changes in meniscal volume over the course of the study as determined by MRI
- Secondary Outcome Measures
Name Time Method Lysholm Knee Scale 2 years Lysholm knee score will be determined according to the questionnaire
Safety Assessment Adverse Event 2 years Number of participants with Adverse Events.
Safety Assessment Immunological 2 years Number of participants with clinically significant abnormalities in immunological measures
Safety Assessment Laboratory 2 years Number of participants with clinically significant abnormalities in laboratory assessments
Quality of Life Questionnaire 2 years Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).
Visual Analog Scale (VAS) Baseline to 2 years Patient perception of pain will be documented using a single VAS pain scale.
Safety Assessment Physical Exam 2 years Number of participants with clinically significant abnormalities in physical examinations.
Safety Assessment Magnetic Resonance Imaging (MRI) 2 years Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).
Trial Locations
- Locations (8)
Orthopedic Center of Vero Beach
🇺🇸Vero Beach, Florida, United States
Ortholndy
🇺🇸Indianapolis, Indiana, United States
Greater Chesapeake Associates
🇺🇸Baltimore, Maryland, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Triangle Orthopaedics Associates, P.A.
🇺🇸Durham, North Carolina, United States
Unlimited Research
🇺🇸San Antonio, Texas, United States
Midwest Orthopaedics at Rush
🇺🇸Chicago, Illinois, United States
TRIA Orthopaedic Center
🇺🇸Bloomington, Minnesota, United States