Clinical trial NCT05440370: Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Cartilage Defects
microfracture
MegaCarti
cartilage regeneration
Lead sponsor: L&C Bio
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: MOCART score
timeFrame: 48 weeks after surgery
Secondary outcomes:
measure: Comparison of IKDC score
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: Comparison of VAS score
timeFrame: Baseline and 6, 12, 24, 48 weeks after surgery
measure: Comparison of KOOS score
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: Comparison of WOMAC score
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: Comparison of Kellgren-Lawrence grade
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: Frequency of rescue medication
timeFrame: For 48 weeks after surgery
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Gangnam Severance Hospital
name: Seong Hwan Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: