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

NCT ID: NCT02524509

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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\*.

Conditions

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

Keywords

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Chonodron Microfracture autologous cultured chondrocyte cartilage defect of knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CHONDRON

Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects

No interventions assigned to this group

Microfracture

patients already underwent microfracture

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myung Goo Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Inha University Medical School Hospital

Locations

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Inha University Medical School Hospital

Incheon, Inchoen, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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07CON

Identifier Type: -

Identifier Source: org_study_id