Phase 2 Clinical Trial of CartiLifeĀ® in the United States (NCT04744402) | Clinical Trial Compass
UnknownPhase 2
Phase 2 Clinical Trial of CartiLifeĀ® in the United States
United States25 participantsStarted 2020-10-28
Plain-language summary
To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLifeĀ®) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Male or female subjects aged over 18 at the time of signing the Informed Consent form
ā. Subject who has a size of the relevant cartilage lesion ā„ 2 cm2 and ā¤ 10 cm2 but with a defect area total volume ā¤ 4 cm3
ā. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
ā. Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
ā. Subject who can move independently and has a mechanically stable knee (normal ligament status)
ā. Subject with intact or partial meniscus status (\>50% of meniscus)
ā. Subject who has KOOS pain value less than 60 at baseline
ā. Subject who agrees to actively participate in a rehabilitation protocol and follow-up program
Exclusion criteria
ā. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
ā. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
ā. Subject who has received an intra-articular treatment within the last 3 months
ā. 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)
What they're measuring
1
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)
Timeframe: Week 0 (pre-operation) to Week 48 (post-operation)
2
Change in volume fill of cartilage defect score
Timeframe: Week 0 (pre-operation) to Week 48 (post-operation)
ā. Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
ā. Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
ā. Subject whose articular cartilage defect is asymptomatic
ā. 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