Study to assess the efficacy and safety of treatment of articular cartilage lesions with CartiLife®.
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001577
- Lead Sponsor
- MCTTBio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1) Adult males and females aged over 19 and under 65
2) Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume)
3) Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
4) The joint space is maintained over 50% relative to baseline
5) Patients with self-reliant behavior
6) Patients understand strict rehabilitation protocol and follow-up program and are willing to follow it.
7) Patients who consented to the clinical trial
1) Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
2) kellgren and Lawrence grade = 3
3) Patients with arthritis associated with autoimmune diseases
4) Patients hypersensitive to bovine protein
5) Patients with Haemophilia or markedly reduced immune function
6) Patients hypersensitive to antibiotics like gentamicin
7) Patients with arterial bleeding and severe venous bleeding
8) Patients with other diseases including tumors except for cartilaginous defects of joints
9) Patients with a history of radiation treatment and chemotherapy within the past two years
10) Patients who are pregnant, nursing a baby or likely to get pregnant
11) Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
12) The other cases of patients which doctors determine not participate in the trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI(Magnetic Resonance Imaging)- MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) scoring
- Secondary Outcome Measures
Name Time Method ysholm score;International knee documentation committee(IKDC) ;Knee Injury and Osteoarthritis Outcome Score(KOOS);100 mm Pain Visual Analogue Scale(VAS);ROM (Range of Motion);Physical examination;Adverse event;Vital signs;MRI(Magnetic Resonance Imaging)- Confirmation of Out growth