Clinical trial to evaluate the efficacy and safety of MegaCarti® in Knee Cartilage Defects
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0004936
- Lead Sponsor
- &C BIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 90
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 ?
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MOCART score
- Secondary Outcome Measures
Name Time Method 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