Osteoarthritis, KneeNCT05440370
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 4 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 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
- 90 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 16 Apr 2020to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years to 65 years
- Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
- Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
- Patients 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 : Below 10 ㎠
Who cannot join
- Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
- Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
- When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
- When screening, Patients who took oral steroid within 1 month
- When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
- Patients taking immunosuppressive drug, or having immune disorder
Show all 17Show fewer
- Patients who can't take MRI scan
- Patients with a history of cancer within the past five years
- Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
- BMI index : 30 ㎏/㎡ or over
- Patients who have gout or gout history in the knee
- When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
- Drug and alcohol addiction / dependence or mental disorder
- Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
- Patients who have systemic or localized knee infection
- Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
- Patients who participated in other clinical trials within three months before screening
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Korea University Anam Hospital
Seoul, 02841
Yonsei University Health System, Severance Hospital
Seoul, 03722
Yonsei University Health System, Gangnam Severance Hospital
Seoul, 06273
About this study
Official title: Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up 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.
The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.
- Conditions
- Osteoarthritis, Knee
- Being tested
- MegaCarti®, Microfracture
- Keywords
- Knee Cartilage Defects, microfracture, 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 | Experimental | The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years. Receives: Device: MegaCarti®; Procedure: Microfracture |
| Microfracture only | Active comparator | The control group undergoes microfracture and they visit at 6 weeks, 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
Primary Endpoint [experimental group / control group]
Measured: 48 weeks after surgery
Secondary outcomes (6)
Comparison of IKDC score
Secondary Endpoint [experimental group / control group]
Measured: Baseline and 12, 24, 48 weeks after surgery
Comparison of VAS score
Secondary Endpoint [experimental group / control group]
Measured: Baseline and 6, 12, 24, 48 weeks after surgery
Comparison of KOOS score
Secondary Endpoint [experimental group / control group]
Measured: Baseline and 12, 24, 48 weeks after surgery
Comparison of WOMAC score
Secondary Endpoint [experimental group / control group]
Measured: Baseline and 12, 24, 48 weeks after surgery
Comparison of Kellgren-Lawrence grade
Secondary Endpoint [experimental group / control group]
Measured: Baseline and 12, 24, 48 weeks after surgery
Frequency of rescue medication
Secondary Endpoint [experimental group / control group]
Measured: For 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 posted30 Jun 2022
- Study start16 Apr 2020
- Primary completion10 Jun 2022
- Study completion31 Jan 2027 (estimated)
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- L&C Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seong Hwan Kim, Professor, Principal investigator, Yonsei University Health System, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440370
- Sponsor's protocol ID
- LNC-MECA-001
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study
- ClinicalTrials.gov ID
- NCT05440370
- Acronym / sponsor ID
- LNC-MECA-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Cartilage Defects, microfracture, MegaCarti, cartilage regeneration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- L&C BioIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Jun 2022 (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.
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.
The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.
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 | Experimental | Device: MegaCarti®, Procedure: MicrofractureThe experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years. |
| Microfracture only | Active comparator | Procedure: MicrofractureThe control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19 years to 65 years
- Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
- Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
- Patients 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 : Below 10 ㎠
Key exclusion criteria (17 listed)
- Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
- Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
- When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
- When screening, Patients who took oral steroid within 1 month
- When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
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 |
| MicrofractureMicrofracture through athroscopic or incision surgery | Procedure or surgery | MegaCarti® application after microfracture, Microfracture only |
Primary outcome
MOCART score
Time frame: 48 weeks after surgery
Primary Endpoint [experimental group / control group]
6 secondary outcomes
Comparison of IKDC score
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of VAS score
Time frame: Baseline and 6, 12, 24, 48 weeks after surgery
Comparison of KOOS score
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of WOMAC score
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of Kellgren-Lawrence grade
Time frame: Baseline and 12, 24, 48 weeks after surgery
Frequency of rescue medication
Time frame: For 48 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- 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.
Seong Hwan Kim, Professor principal investigator
Yonsei University Health System, Gangnam Severance Hospital
4 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 4 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 17 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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: 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 30 Jun 2022.