Evaluating MegaCarti® for knee cartilage defects
A Clinical Trial to Evaluate the Efficacy and Safety of Cartilage Regeneration in the Use of MegaCarti^® in Patients with Knee Joint Cartilage Injury: Multicenter, Independent Evaluator-subject Blinded, Microfracture-comparative, Randomized Clinical Study
This study is testing if adding MegaCarti® to a standard knee treatment can help people aged 50 to 65 with knee cartilage defects recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | L&C Bio Industry-sponsored |
| Locations | 6 sites (Gyeonggi-do and 5 other locations) |
| Trial ID | NCT06249828 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on subjects aged 50 to 65 years who have knee cartilage defects. Participants will undergo a microfracture treatment followed by the application of MegaCarti®, a decellularized allogeneic cartilage designed to enhance cartilage regeneration. The efficacy of this approach will be assessed by comparing outcomes with a control group receiving only microfracture treatment, using MOCART evaluation and biopsy to measure cartilage regeneration at 48 weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 65 with localized full-thickness cartilage defects in the knee joint, specifically ICRS Grade III or IV.
Not a fit: Patients with autoimmune diseases or those who have had recent cartilage defect treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cartilage regeneration in patients with knee defects, potentially alleviating pain and restoring function.
How similar studies have performed: While the use of decellularized cartilage is a growing area of interest, this specific application of MegaCarti® in conjunction with microfracture is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 50 years to 65 yaers 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: 1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) 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
Where this trial is running
Gyeonggi-do and 5 other locations
- Chung-Ang University Gwangmyeong Hospital — Gyeonggi-do, Korea, Republic of (Recruiting)
- Ajou University Medical Center — Gyeonggi-do, Korea, Republic of (Recruiting)
- Catholic Kwandong University International St.Mary's Hospital — Incheon, Korea, Republic of (Recruiting)
- Konkuk University Medical Center — Seoul, Korea, Republic of (Recruiting)
- Yonsei University Health System, Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Yonsei Sarang Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: JY Ahn
- Email: sarahahn@lncbio.co.kr
- Phone: 822- 070-7791-2290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.