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Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

NCT03545269 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-06-04

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.

Conditions

  • Articular Cartilage Lesion of the Knee

Interventions

DRUG

CartiLife®

CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.

PROCEDURE

Microfracture

The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Sponsors & Collaborators

  • Kyunghee University Medical Center

    collaborator OTHER

  • Gangnam Severance Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Ewha Womans University

    collaborator OTHER

  • Biosolution Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyoung Ho, MD, PhD · Kyunghee University Medical Center

  • Jong Hyeok Choi, MD, PhD · Severance Hospital

  • Jae-Doo Yoo, MD, PhD · Ewha Womans University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-03
Primary Completion
2017-02-23
Completion
2017-02-23

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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 NCT03545269 on ClinicalTrials.gov