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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Device: MegaCarti®; Procedure: Microfracture

• Registration Number: NCT05440370
• Lead Sponsor: L&C Bio

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Status Verified: 2022-06
• Primary Completion: 2022-06-10
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Study First Posted: 2022-06-30
• Last Update Posted: 2022-06-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. 19 years to 65 years
2. Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
3. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
4. 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
5. knee cartilage defect size : Below 10 ㎠

Exclusion Criteria

1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
2. Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
4. When screening, Patients who took oral steroid within 1 month
5. When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
6. Patients taking immunosuppressive drug, or having immune disorder
7. Patients who can't take MRI scan
8. Patients with a history of cancer within the past five years
9. Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
10. BMI index : 30 ㎏/㎡ or over
11. Patients who have gout or gout history in the knee
12. 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.
13. Drug and alcohol addiction / dependence or mental disorder
14. Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
15. Patients who have systemic or localized knee infection
16. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
17. Patients who participated in other clinical trials within three months before screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MegaCarti® application after microfracture	MegaCarti®	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.
Microfracture only	Microfracture	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.
MegaCarti® application after microfracture	Microfracture	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.

Primary Outcome Measures

Name	Time	Method
MOCART score	48 weeks after surgery	Primary Endpoint \[experimental group / control group\]

Secondary Outcome Measures

Name	Time	Method
Comparison of KOOS score	Baseline and 12, 24, 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]
Comparison of IKDC score	Baseline and 12, 24, 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]
Comparison of WOMAC score	Baseline and 12, 24, 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]
Comparison of VAS score	Baseline and 6, 12, 24, 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]
Frequency of rescue medication	For 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]
Comparison of Kellgren-Lawrence grade	Baseline and 12, 24, 48 weeks after surgery	Secondary Endpoint \[experimental group / control group\]

Trial Locations

Locations (4)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of