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

Defect of Articular Cartilage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02524509
• Other study ID #: 07CON
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 13, 2015
• Last updated: August 28, 2015
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial Summary

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

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*.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Cartilage Diseases
• Defect of Articular Cartilage
• Degeneration; Articular Cartilage, Knee

Locations

Country	Name	City	State
Korea, Republic of	Inha University Medical School Hospital	Incheon	Inchoen

Sponsors (1)

Lead Sponsor	Collaborator
Sewon Cellontech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No