Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects

Study Overview
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Brief Summary
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The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.

Official Title
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Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: MegaCarti®
* Procedure: Microfracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years to 65 years Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage 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 knee cartilage defect size : Below 10 ㎠ Exclusion Criteria: Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery) When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months When screening, Patients who took oral steroid within 1 month When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests Patients taking immunosuppressive drug, or having immune disorder Patients who can't take MRI scan Patients with a history of cancer within the past five years Patients who have chronic renal failure, active hepatitis, or poor blood sugar control BMI index : 30 ㎏/㎡ or over Patients who have gout or gout history in the knee 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. Drug and alcohol addiction / dependence or mental disorder Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin) Patients who have systemic or localized knee infection Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial Patients who participated in other clinical trials within three months before screening

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MegaCarti® application after microfracture<br>The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years. | Device: MegaCarti®<br>* MegaCarti® application after microfracture through athroscopic or incision surgery<br>Procedure: Microfracture<br>* Microfracture through athroscopic or incision surgery<br>|
| Active Comparator: Microfracture only<br>The control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires. | Procedure: Microfracture<br>* Microfracture through athroscopic or incision surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOCART score | Primary Endpoint [experimental group / control group] | 48 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of IKDC score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery | 
| Comparison of VAS score | Secondary Endpoint [experimental group / control group] | Baseline and 6, 12, 24, 48 weeks after surgery | 
| Comparison of KOOS score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery | 
| Comparison of WOMAC score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery | 
| Comparison of Kellgren-Lawrence grade | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery | 
| Frequency of rescue medication | Secondary Endpoint [experimental group / control group] | For 48 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Cartilage Defects, microfracture, MegaCarti, cartilage regeneration