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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05440370
• Other study ID #: LNC-MECA-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: January 31, 2027

Study information

• Verified date: June 2022
• Source: L&C Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 31, 2027
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• MegaCarti®
MegaCarti® application after microfracture through athroscopic or incision surgery

Procedure:
• Microfracture
Microfracture through athroscopic or incision surgery

Locations

Country	Name	City	State
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Gangnam Severance Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
L&C Bio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOCART score	Primary Endpoint [experimental group / control group]	48 weeks after surgery
Secondary	Comparison of IKDC score	Secondary Endpoint [experimental group / control group]	Baseline and 12, 24, 48 weeks after surgery
Secondary	Comparison of VAS score	Secondary Endpoint [experimental group / control group]	Baseline and 6, 12, 24, 48 weeks after surgery
Secondary	Comparison of KOOS score	Secondary Endpoint [experimental group / control group]	Baseline and 12, 24, 48 weeks after surgery
Secondary	Comparison of WOMAC score	Secondary Endpoint [experimental group / control group]	Baseline and 12, 24, 48 weeks after surgery
Secondary	Comparison of Kellgren-Lawrence grade	Secondary Endpoint [experimental group / control group]	Baseline and 12, 24, 48 weeks after surgery
Secondary	Frequency of rescue medication	Secondary Endpoint [experimental group / control group]	For 48 weeks after surgery