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

NCT03517046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-07

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 chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.

Conditions

  • Articular Cartilage Lesion of Knee

Interventions

DRUG

CartiLife

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

Sponsors & Collaborators

  • Kyung Hee University Hospital

    collaborator OTHER

  • Biosolution Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-17
Primary Completion
2013-12-10
Completion
2013-12-10

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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 NCT03517046 on ClinicalTrials.gov