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Completed

NCT Number: NCT06249828

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

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Fractures, Bone Fractures, Stress Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Medical Center, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients with risk factor for bleeding
  • Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial

Treatment and study plan

MegaCarti®

Device

MegaCarti® application after microfracture through athroscopic or incision surgery

Microfracture

Procedure

Microfracture through athroscopic or incision surgery

Primary outcomes

  1. MOCART score

    Time frame: From 48 weeks after surgery

    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.

Secondary outcomes

  1. IKDC score

    Time frame: Baseline and 12, 24, 48 weeks after surgery

    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.

  2. VAS

    Time frame: Baseline and 12, 24, 48 weeks after surgery

    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.

  3. KOOS

    Time frame: Baseline and 12, 24, 48 weeks after surgery

    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.

  4. ICRS-CRA score

    Time frame: From 48 weeks after surgery

    Investigator uses the International Cartilage Repair Society (ICRS) - cartilage repair assessment grading (CRA) system to evaluate the degree of cartilage regeneration.

  5. OAS

    Time frame: From 48 weeks after surgery

    Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration.

  6. Cartilage Coverage Ratio

    Time frame: From 48 weeks after surgery

    Using arthroscopy, the investigator calculates the area of repaired cartilage that is greater than 75% defect depth.

  7. Histological Evaluation

    Time frame: From 48 weeks after surgery

    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.

Sponsors and collaborators

Lead sponsor

L&C Bio

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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