None listed
Conditions
Interventions
Medical Device : Patients who meet the inclusion/exclusion criteria are divided into experimental and control groups through randomization.
The experimental group is applied with MegaCarti® after mic
Sponsors
L&C BIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 19 years to 65 years 2) Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form. 3) Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage 4) Patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms 5) knee cartilage defect size : Below 10 ?
Exclusion criteria
Exclusion criteria: 1) Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) 2) Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery) 3) When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months 4) When screening, Patients who took oral steroid within 1 month 5) When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests 6) Patients taking immunosuppressive drug, or having immune disorder 7) Patients who can’t take MRI scan 8) Patients with a history of cancer within the past five years 9) Patients who have chronic renal failure, active hepatitis, or poor blood sugar control 10) BMI index : 30kg/m2 or over 11) Patients who have gout or gout history in the knee 12) When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. 13) Drug and alcohol addiction / dependence or mental disorder 14) Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin) 15) Patients who have systemic or localized knee infection 16) Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial 17) Patients who participated in other clinical trials within three months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MOCART score | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of IKDC score;Comparison of VAS score;Comparison of KOOS score;Comparison of WOMAC score;Comparison of Kellgren-Lawrence grade;Frequency of rescue medication | — |
Countries
Korea, Republic of
Contacts
Public ContactGaram Park
L&C BIO
Outcome results
None listed