Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05440370
NA

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

Sponsor: L&C Bio

View on ClinicalTrials.gov

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

Interventions

DEVICE

MegaCarti®

MegaCarti® application after microfracture through athroscopic or incision surgery

PROCEDURE

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