the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee

An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Knee Joint

The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.

Study Overview

• Status: Unknown
• Conditions: Defect of Articular Cartilage; Articular Cartilage Disorder of Knee; Degeneration; Articular Cartilage, Knee

Detailed Description

It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time*.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Korea, Republic of
  • Inchoen
    • Incheon, Inchoen, Korea, Republic of
      • Inha University Medical School Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Total 50 patients. Patients who received autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) for knee osteoarthritis or patients underwent microfracture. There are total 28 patients who get CHONDRON grafting until now. Considering dropout rate, the selected number of investigational group is total 25, and 25 of equivalent control group is planned.

Description

Inclusion Criteria:

- 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.

2. Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form

Exclusion Criteria:

- 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.

2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CHONDRON; Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects
Microfracture; patients already underwent microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score change of KOOS(Knee Injury and Osteoarthritis Outcome)	comparison of the difference between a group with Chondron Implantation and a group with Microfracture.	Screening, post op 2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score change of 100 Vas(visual Analog System)	Comparison the difference between a group with Chondron Implantation and a group with Microfracture	Screening, post op 2years
Score change of IKDC (International Knee Documentation Committee)	comparison the difference between a group with Chondron Implantation and a group with Microfracture	screening, post op 2 years
Score change of KSS(Knee Society Score)	Comparision the difference between a group with Chondron Implantation and a group with Microfracture.	Screening, Post op 2 years
Comparing MRI results	Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture	Screening, Post op 2years

Collaborators and Investigators

• Sponsor: Sewon Cellontech Co., Ltd.
• Investigators: Principal Investigator: Myung Goo Kim, MD, Inha University Medical School Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Chonodron; Microfracture; autologous cultured chondrocyte; cartilage defect of knee
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: 07CON