Osteoarthritis, KneeNCT06249828
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
A study testing MegaCarti® and Microfracture in people with Osteoarthritis, Knee, run by L&C Bio at 7 sites in South Korea.
Trial summary
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- MegaCarti® and Microfracture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 22 Jan 2024to 13 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, 14353
Ajou University Medical Center
Gyeonggi-do, 16499
Catholic Kwandong University International St.Mary's Hospital
Incheon
Yonsei University Health System, Severance Hospital
Seoul, 03722
Konkuk University Medical Center
Seoul, 05030
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, 06273
Yonsei Sarang Hospital
Seoul, 06702
About this study
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
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- MegaCarti®, Microfracture
- Keywords
- Knee Cartilage Defects, Microfracture, HTO, High Tibia Osteotomy, MegaCarti, Cartilage regeneration
- Medical subject headings
- Osteoarthritis, Knee, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MegaCarti®Device
MegaCarti® application after microfracture through athroscopic or incision surgery
MicrofractureProcedure or surgery
Microfracture through athroscopic or incision surgery
| Study group | Role | What they receive |
|---|---|---|
| MegaCarti® application after Microfracture Surgery | Experimental | 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. Receives: Device: MegaCarti®; Procedure: Microfracture |
| Microfracture Surgery without Medical Devices | Active comparator | The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 48 weeks after surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 48 weeks after surgery
OAS
Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration.
Measured: 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.
Measured: 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.
Measured: From 48 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start22 Jan 2024
- Primary completion13 Dec 2025
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- L&C Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunghwan kim, Study director, Yonsei University College of Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249828
- Sponsor's protocol ID
- LNC-MECA-004
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06249828
- Acronym / sponsor ID
- LNC-MECA-004
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Cartilage Defects, Microfracture, HTO, High Tibia Osteotomy, MegaCarti, Cartilage regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- L&C BioIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MegaCarti® application after Microfracture Surgery | Experimental | Device: MegaCarti®, Procedure: MicrofractureThe 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. |
| Microfracture Surgery without Medical Devices | Active comparator | Procedure: MicrofractureThe control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MegaCarti®MegaCarti® application after microfracture through athroscopic or incision surgery | Device | MegaCarti® application after Microfracture Surgery |
| MicrofractureMicrofracture through athroscopic or incision surgery | Procedure or surgery | MegaCarti® application after Microfracture Surgery, Microfracture Surgery without Medical Devices |
Primary outcome
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.
7 secondary outcomes
IKDC score
Time frame: Baseline and 12, 24, 48 weeks after surgery
VAS
Time frame: Baseline and 12, 24, 48 weeks after surgery
KOOS
Time frame: Baseline and 12, 24, 48 weeks after surgery
ICRS-CRA score
Time frame: From 48 weeks after surgery
OAS
Time frame: From 48 weeks after surgery
Cartilage Coverage Ratio
Time frame: From 48 weeks after surgery
Histological Evaluation
Time frame: From 48 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunghwan kim study director
Yonsei University College of Medicine, Severance Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MegaCarti® and Microfracture in people with Osteoarthritis, Knee, run by L&C Bio at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCART score (time frame: From 48 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.