Phase 3 Clinical Trial of CartiLifeĀ® in Korea (NCT05051332) | Clinical Trial Compass
UnknownPhase 3
Phase 3 Clinical Trial of CartiLifeĀ® in Korea
South Korea104 participantsStarted 2020-03-19
Plain-language summary
To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLifeĀ®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.
Who can participate
Age range18 Years ā 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Patients over the age of 18.
ā. Defect size: 2 to 10 cm\^2 on the unilateral knee cartilage (up to 4 ć¤ in volume).
ā. Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 \~ 2).
ā. Patients with a KOOS total score below 55.
ā. Patients able to walk without aid.
ā. Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
ā. Patients who provide written consent to the application of the clinical trial.
Exclusion criteria
ā. Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
ā. Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
ā. Patients with inflammatory articular diseases related to autoimmune diseases.
ā. Patients hypersensitive to bovine derived proteins or any of the components in this product.
ā. Patients hypersensitive to Gentamycin.
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What they're measuring
1
MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)