Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application

Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study

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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: microfracture; Device: MegaCarti®

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Yonsei University Health System, Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent HTO were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.

Description

Inclusion Criteria:

1. Patients participating in the "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"
2. Patients who simultaneously underwent HTO during knee joint cartilage surgery

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MegaCarti®; Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture.	Procedure: microfracture; microfracture; Device: MegaCarti®; Medical devices containing allogeneic cartilage
Microfracture only; The control group underwent microfracture and high tibial osteotomy(HTO)	Procedure: microfracture; microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment	Primary Endpoint [experimental group / control group]	When removing fixtures after HTO (an average of 1 year after surgery)
Comparison of macroscopic status of regenerated cartilage	Primary Endpoint [experimental group / control group]	When removing fixtures after HTO (an average of 1 year after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of IKDC score	Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome	At last visit (an average of two years after surgery)
Comparison of VAS score	Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome	At last visit (an average of two years after surgery)
Comparison of KOOS score	Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome	At last visit (an average of two years after surgery)
Comparison of WOMAC score	Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome	At last visit (an average of two years after surgery)
Comparison of Kellgren-Lawrence grade	Secondary Endpoint [experimental group / control group]	At last visit (an average of two years after surgery)
Comparison of HKA angle, Posterior Tibial slope	Secondary Endpoint [experimental group / control group]	At last visit (an average of two years after surgery)

Collaborators and Investigators

• Sponsor: L&C Bio

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: LNC-MECA-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No