Study to assess the safety of treatment of articular cartilage lesions with CartiLife®.
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000560
- Lead Sponsor
- MCTT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
1)Adult males and females aged over 19
2)Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume)
3)Defect: isolated 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)Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial
1)Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
2)Patients with arthritis associated with autoimmune diseases
3)Patients hypersensitive to bovine protein
4)Patients with Haemophilia or markedly reduced immune function
5)Patients hypersensitive to antibiotics like gentamicin
6)Patients with arterial bleeding and severe venous bleeding
7)Patients with other diseases including tumors except for cartilaginous defects of joints
8)Patients with a history of radiation treatment and chemotherapy within the past two years
9)Patients who are pregnant, nursing a baby or likely to get pregnant
10)Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
11)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 Safety (Vital signs, Physical examnination, Laboratory test, Immunoassay);Adverse event;Efficacy (IKDC, X-ray)
- Secondary Outcome Measures
Name Time Method Safety (Vital signs, Physical examnination)