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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: MegaCarti®; Procedure: Microfracture

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do, South Korea, 16499
    • Ajou University Medical Center
  • Gyeonggi-do, South Korea, 14353
    • Chung-Ang University Gwangmyeong Hospital
  • Incheon, South Korea
    • Catholic Kwandong University International St.Mary's Hospital
  • Seoul, South Korea, 03722
    • Yonsei University Health System, Severance Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 06273
    • Yonsei University College of Medicine, Gangnam Severance Hospital
  • Seoul, South Korea, 06702
    • Yonsei Sarang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 50 years to 65 years
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Microfracture; Microfracture through athroscopic or incision surgery
Experimental: 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.	Device: MegaCarti®; MegaCarti® application after microfracture through athroscopic or incision surgery; Procedure: Microfracture; Microfracture through athroscopic or incision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MOCART score	The independent evaluator measure the MOCART score based on the MRI images taken at 48 weeks after surgery. The MOCART score is an index for evaluating the degree of restoration of cartilage tissue and consists of a total of 9 items. Each item is scored from 0 to a maximum of 20 points and added up. The MOCART score is 0 when the cartilage is in the worst condition, and 100 when it is in the best condition. In other words, when the clinical effect of tissue repair appears, it is evaluated as a score greater than 0.	From 48 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC score	Subjects underwent a self-assessment of knee function using the International Knee Documentation Committee Assessment (IKDC). The outcome was presented with the post-operative change amount from the baseline.	Baseline and 12, 24, 48 weeks after surgery
VAS	Subjects underwent a self-assessment of knee joint pain using the 100-mm Visual Analogue Scale (VAS). Use of NSAIDs and acetaminophen have to be discontinued for 24 hours, respectively, prior to the VAS evaluation. The outcome was presented with the post-operative change amount from the baseline.	Baseline and 12, 24, 48 weeks after surgery
KOOS	Subjects underwent a self-assessment of knee joint pain using the Knee Injury and Osteoarthritis Outcome score (KOOS) survey. The outcome was presented with the post-operative change amount from the baseline.	Baseline and 12, 24, 48 weeks after surgery
ICRS-CRA score	Investigator uses the International Cartilage Repair Society (ICRS) - cartilage repair assessment grading (CRA) system to evaluate the degree of cartilage regeneration.	From 48 weeks after surgery
OAS	Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration.	From 48 weeks after surgery
Cartilage Coverage Ratio	Using arthroscopy, the investigator calculates the area of repaired cartilage that is greater than 75% defect depth.	From 48 weeks after surgery
Histological Evaluation	Cartilage tissue is collected from the center of the repaired knee cartilage using a needle punch. After the collected tissue is stained, an independent evaluator evaluates it using the ICRS-II Parameters evaluation sheet.	From 48 weeks after surgery

Collaborators and Investigators

• Sponsor: L&C Bio
• Collaborators: PROMeDis
• Investigators: Study Director: Sunghwan kim, Yonsei University College of Medicine, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): December 13, 2025
• Study Completion (Actual): December 13, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cartilage regeneration; Microfracture; Knee Cartilage Defects; MegaCarti; HTO; High Tibia Osteotomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rheumatic Diseases; Fractures, Bone; Osteoarthritis; Osteoarthritis, Knee; Fractures, Stress; Surgical Procedures, Operative; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Arthroplasty, Subchondral
• Other Study ID Numbers: LNC-MECA-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No