Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti^® in Knee Cartilage Defects
NCT ID: NCT06249828
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-01-22
2026-01-31
Brief Summary
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Detailed Description
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To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MegaCarti^® application after Microfracture Surgery
The study group is applied with MegaCarti\^® after microfracture. Afterwards, they visit at 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires.
MegaCarti^®
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture
Microfracture through athroscopic or incision surgery
Microfracture Surgery without Medical Devices
The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
Microfracture
Microfracture through athroscopic or incision surgery
Interventions
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MegaCarti^®
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture
Microfracture through athroscopic or incision surgery
Eligibility Criteria
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Inclusion Criteria
2. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form
3. Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
4. Subjects 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 :1.5cm\^2 to 10cm\^2
Exclusion Criteria
2. When screening, Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (However, arthroscopy for diagnostic purposes is possible. Additionally, it is possible if hightibial osteotomy (HTO) has been performed in advance or is scheduled)
3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
4. When screening, Patients who took oral steroid within 2 weeks
5. Patients who can't take MRI scan
6. BMI index : 30kg/m\^2 or over
7. Patients who have gout or gout history in the knee
8. Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
9. Patients with risk factor for bleeding
10. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
50 Years
65 Years
ALL
No
Sponsors
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L&C Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Sunghwan kim
Role: STUDY_DIRECTOR
Yonsei University College of Medicine Gangnam severance Hospital
Junyoung Chung
Role: STUDY_DIRECTOR
Ajou University Medical Center
Junkyu Lee
Role: STUDY_DIRECTOR
Konkuk University Medical Center
Yongbum Park
Role: STUDY_DIRECTOR
Chung-Ang University Gwangmyeong Hospital
Locations
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Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, , South Korea
Ajou University Medical Center
Gyeonggi-do, , South Korea
Catholic Kwandong University International St.Mary's Hospital
Incheon, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, , South Korea
Yonsei Sarang Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LNC-MECA-004
Identifier Type: -
Identifier Source: org_study_id
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