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

NCT05440370 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-06-30

No results posted yet for this study

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

DEVICE

MegaCarti®

MegaCarti® application after microfracture through athroscopic or incision surgery

PROCEDURE

Microfracture

Microfracture through athroscopic or incision surgery

Sponsors & Collaborators

  • L&C Bio

    lead INDUSTRY

Principal Investigators

  • Seong Hwan Kim, Professor · Yonsei University Health System, Gangnam Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2022-06-10
Completion
2027-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440370 on ClinicalTrials.gov