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

L&C Bio

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Device: MegaCarti^®; Procedure: Microfracture

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06249828

LNC-MECA-004

Details and patient eligibility

About

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

Full description

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.

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

MegaCarti^® application after Microfracture Surgery

Experimental group

Description:

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:

Procedure: Microfracture

Device: MegaCarti^®

Microfracture Surgery without Medical Devices

Active Comparator group

Description:

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:

Procedure: Microfracture