KCT0000560
Completed
未知
A multi-center, Open-label, Phase I trial to assess the safety for treatment of autologous chondrocytes implantation with CartiLife for patients with chondral defects in the knee
MCTT0 sites6 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Sponsor
- MCTT
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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