A study on the efficacy and safety evaluation betweenAutologous Chondrocytes Implantation with CartiLife versus Microfracture for Patients with Knee Chondral Defects
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004966
- Lead Sponsor
- Biosolutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 104
1. subject who aged greater than 18 years, but less than 65 years
2. Subject who has a size of the relevant cartilage lesion greater than 2 ?, but less than 10 ? (total volume considering the depth should not exceed 4 ?.)
3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage. Subject with relatively healthy cartilage (ICRS Grade?~?) around the area of damaged cartilage
4. Subject who has KOOS pain value less than 55 at baseline
5. Subject with self-reliant behavior
6. Subject who agrees to follow recommended physical therapy including exercise conducted in the home
7. Subject who is able to provide informed consent and comply with study requirements
1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
2. Subject with Kellgren and Lawrence grade ? or higher
3. Subject with arthritis associated with autoimmune disease
4. Subject who has a history of hypersensitivity to bovine protein or the composition of the drug
5. Subject who has a history of hypersensitivity to gentamicin
6. Subject with Hemophilia or markedly reduced immune function
7. Subject with arterial bleeding and severe venous bleeding
8. Subject with other diseases including tumors except for cartilaginous defects of joints
9. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
10. Subject who is currently pregnant or nursing
11. Subject who participates in concurrent trials or in previous trial within 30days of signing in formed consent
12. Subject who had any medical condition that can hinder the efficacy or safety evaluation of the investigational drug or did not complete this study as investigator comment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method