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

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ClinicalTrials.gov Identifier: NCT02524509
Recruitment Status : Unknown
Verified August 2015 by Sewon Cellontech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Sewon Cellontech Co., Ltd.

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

Condition or disease
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*.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : January 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

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



Primary Outcome Measures :
  1. Score change of KOOS(Knee Injury and Osteoarthritis Outcome) [ Time Frame: Screening, post op 2years ]
    comparison of the difference between a group with Chondron Implantation and a group with Microfracture.


Secondary Outcome Measures :
  1. Score change of 100 Vas(visual Analog System) [ Time Frame: Screening, post op 2years ]
    Comparison the difference between a group with Chondron Implantation and a group with Microfracture

  2. Score change of IKDC (International Knee Documentation Committee) [ Time Frame: screening, post op 2 years ]
    comparison the difference between a group with Chondron Implantation and a group with Microfracture

  3. Score change of KSS(Knee Society Score) [ Time Frame: Screening, Post op 2 years ]
    Comparision the difference between a group with Chondron Implantation and a group with Microfracture.

  4. Comparing MRI results [ Time Frame: Screening, Post op 2years ]
    Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524509


Locations
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Korea, Republic of
Inha University Medical School Hospital
Incheon, Inchoen, Korea, Republic of
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
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Principal Investigator: Myung Goo Kim, MD Inha University Medical School Hospital

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Responsible Party: Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02524509     History of Changes
Other Study ID Numbers: 07CON
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Sewon Cellontech Co., Ltd.:
Chonodron
Microfracture
autologous cultured chondrocyte
cartilage defect of knee
Additional relevant MeSH terms:
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Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases