KCT0004936
Active, not recruiting
未知
Clinical trial to evaluate the efficacy and safety of MegaCarti® ; cartilage defect treatment assisting cartilage regeneration in Knee Cartilage Defects : Multicenter, independent evaluator subject blinded, microfracture comparative, superiority, randomized, confirmatory clinical study and 5 years follow up study
&C BIO0 sites90 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Sponsor
- &C BIO
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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