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

Information source: Sewon Cellontech Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Defect of Articular Cartilage; Articular Cartilage Disorder of Knee; Degeneration; Articular Cartilage, Knee

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Sewon Cellontech Co., Ltd.

Official(s) and/or principal investigator(s):
Myung Goo Kim, MD, Principal Investigator, Affiliation: Inha University Medical School Hospital

Summary

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

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Score change of KOOS(Knee Injury and Osteoarthritis Outcome)

Secondary outcome:

Score change of 100 Vas(visual Analog System)

Score change of IKDC (International Knee Documentation Committee)

Score change of KSS(Knee Society Score)

Comparing MRI results

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*.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Inha University Medical School Hospital, Incheon, Inchoen, Korea, Republic of
Additional Information

Starting date: January 2012
Last updated: August 13, 2015

Page last updated: August 20, 2015

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