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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
University of Southern California
Los Angeles, California, United States
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Ortholndy
Indianapolis, Indiana, United States
Meniscal Volume
Changes in meniscal volume over the course of the study as determined by MRI
Time frame: 6 months
Quality of Life Questionnaire
Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).
Time frame: 2 years
Visual Analog Scale (VAS)
Patient perception of pain will be documented using a single VAS pain scale.
Time frame: Baseline to 2 years
Lysholm Knee Scale
Lysholm knee score will be determined according to the questionnaire
Time frame: 2 years
Safety Assessment Adverse Event
Number of participants with Adverse Events.
Time frame: 2 years
Safety Assessment Immunological
Number of participants with clinically significant abnormalities in immunological measures
Time frame: 2 years
Safety Assessment Laboratory
Number of participants with clinically significant abnormalities in laboratory assessments
Time frame: 2 years
Safety Assessment Physical Exam
Number of participants with clinically significant abnormalities in physical examinations.
Time frame: 2 years
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Greater Chesapeake Associates
Baltimore, Maryland, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, United States
Unlimited Research
San Antonio, Texas, United States
Safety Assessment Magnetic Resonance Imaging (MRI)
Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).
Time frame: 2 years