None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell, Procedure/Surgery : Investigational group: CartiLife®
Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1 to 1.5 mm in d
Sponsors
Biosolutions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) score;KOOS (Knee injury Osteoarthritis Outcome Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| MOCART scores(item/ Total score) and change from Screening(Visit 1);Lysholm score;IKDC (International Knee Documentation Committee) score;KOOS (Knee injury Osteoarthritis Outcome Score);Tegner activity score;VAS (100 mm Pain Visual Analogue Scale);Radiographic evaluation;Evaluation of biochemical characteristics of regenerated cartilage through MRI _ T2 mapping;Dose frequency and dose of analgesic drug | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Hong
Kyung Hee University Hospital
Outcome results
None listed