CompletedNo phase
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
Key facts
- Who runs it
- L&C Bio
- Where
- South Korea7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 61 people enrolled
- Started
- 22 Jan 2024
- Ended
- 13 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MegaCarti®
- Microfracture
- Record updated
- 25 February 2026
Who can take part
- Age
- 50 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 have autoimmune diseases (Ex. Rheumatoid arthritis)
- Patients with risk factor for bleeding
- 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
- Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
The 2 groups in the trial
- MegaCarti® application after Microfracture SurgeryTreatment being tested
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.
Treatment: MegaCarti® and Microfracture
- Microfracture Surgery without Medical DevicesExisting treatment, for comparison
The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
Treatment: Microfracture
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 25 February 2026