Recovery Following Partial Medial Meniscectomy
Conditions
Keywords
meniscectomy, Chondrogen, Mesenchymal Stem Cells, Osiris
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.
Interventions
DRUGMesenchymal Stem Cells
DRUGHyaluronan
Sponsors
University of Southern California
Midwest Orthopedics at Rush - Chicago, IL
Unlimited Research - San Antonio, TX
Triangle Orthopaedic Associates, P.A.
Orthopedic Center of Vero Beach - Vero Beach, FL
OrthoIndy
TRIA Orthopaedic Center
Greater Chesapeake Orthopaedic Associates, LLC
Mesoblast International Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meniscal Volume | 6 months | Changes in meniscal volume over the course of the study as determined by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Baseline to 2 years | Patient perception of pain will be documented using a single VAS pain scale. |
| 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. |
| Quality of Life Questionnaire | 2 years | Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score). |
| Safety Assessment Laboratory | 2 years | Number of participants with clinically significant abnormalities in laboratory assessments |
| 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). |
| Safety Assessment Immunological | 2 years | Number of participants with clinically significant abnormalities in immunological measures |
Countries
United States
Outcome results
None listed