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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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05440370
Study type Interventional
Source L&C Bio
Contact
Status Active, not recruiting
Phase N/A
Start date April 16, 2020
Completion date January 31, 2027
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