NCT05440370

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: L&C Bio · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	MegaCarti®	MegaCarti® application after microfracture through athroscopic or incision surgery
PROCEDURE	Microfracture	Microfracture through athroscopic or incision surgery

Timeline

• Start date: 2020-04-16
• Primary completion: 2022-06-10
• Completion: 2027-01-31
• First posted: 2022-06-30
• Last updated: 2022-06-30

Locations

4 sites across 1 country: South Korea