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Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
Sponsor: L&C Bio
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.
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
Key Details
Gender
All
Age Range
19 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2020-04-16
Completion Date
2027-01-31
Last Updated
2022-06-30
Healthy Volunteers
No
Conditions
Interventions
MegaCarti®
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture
Microfracture through athroscopic or incision surgery
Locations (4)
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea