Status:
ACTIVE_NOT_RECRUITING
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
Lead Sponsor:
L&C Bio
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
19-65 years
Phase:
NA
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 lo...
Eligibility Criteria
Inclusion
- 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 ㎠
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05440370
Start Date
April 16 2020
End Date
January 31 2027
Last Update
June 30 2022
Active Locations (4)
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1
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10444
2
Korea University Anam Hospital
Seoul, South Korea, 02841
3
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
4
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea, 06273