Status and phase
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About
To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.
Full description
This open-label, phase 2 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.
Enrollment
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Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following:
Exclusion criteria
Individuals who meet any of the following will be excluded from participation in this study:
Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
Subject who has received an intra-articular treatment within the last 3 months
Subject who has had a surgical procedure on the knees within the last 6 weeks (Subjects can be considered enrollment per the investigator's discretion)
Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
Subject whose articular cartilage defect is asymptomatic
Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial, including but not limited to diabetes not adequately controlled, bleeding diathesis or hematologic disease, endocrinopathies, cardiovascular disease, renal disease (severe renal impairment), autoimmune disease, inflammatory arthritis, and current infectious disease
Subject with other diseases including tumors except for cartilaginous defects of joints
Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
Subject who is currently pregnant or nursing
Subject who has any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
Subject who has ligament instability > Grade 1
Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Central trial contact
TaeKyung Kim, MA; Jungsun Lee, Ph.D
Data sourced from clinicaltrials.gov
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