CompletedNot Applicable

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

South Korea61 participantsStarted 2024-01-22

Plain-language summary

Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.

Who can participate

Age range50 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 50 years to 65 years
✓. 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
✓. Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
✓. 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
✓. knee cartilage defect size :1.5cm\^2 to 10cm\^2

Exclusion criteria

✕. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
✕. 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)
✕. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
✕. When screening, Patients who took oral steroid within 2 weeks
✕. Patients who can't take MRI scan
✕. BMI index : 30kg/m\^2 or over
✕. Patients who have gout or gout history in the knee
✕. Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.

What they're measuring

MOCART score

Timeframe: From 48 weeks after surgery

Trial details

NCT IDNCT06249828

SponsorL&C Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-13

View on ClinicalTrials.gov More Osteoarthritis, Knee trials