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
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 |
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inha University Medical School Hospital | Incheon | Inchoen |
Lead Sponsor | Collaborator |
---|---|
Sewon Cellontech Co., Ltd. |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01473199 -
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
|
N/A | |
Active, not recruiting |
NCT01670617 -
DeNovo NT Natural Tissue Graft Stratified Knee Study
|
N/A | |
Active, not recruiting |
NCT01347892 -
DeNovo NT Ankle LDC Study
|
N/A | |
Completed |
NCT02203071 -
Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
|
||
Completed |
NCT01626677 -
Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
|
Phase 3 | |
Active, not recruiting |
NCT02855073 -
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
|
Phase 2 | |
Completed |
NCT01290991 -
A Study to Evaluate the Safety of Augmentâ„¢ Bone Graft
|
N/A | |
Terminated |
NCT01400607 -
Neocartilage Implant to Treat Cartilage Lesions of the Knee
|
Phase 3 | |
Terminated |
NCT00881023 -
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
|
N/A | |
Terminated |
NCT02542566 -
Protected Versus Early Weight Bearing Post Microfracture Surgery
|
N/A | |
Completed |
NCT02696876 -
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
|
N/A | |
Active, not recruiting |
NCT02537067 -
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
|
Phase 3 | |
Recruiting |
NCT02519881 -
the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
|
Phase 4 | |
Active, not recruiting |
NCT02539030 -
Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
|
Phase 4 | |
Active, not recruiting |
NCT02659215 -
HyaloFAST Trial for Repair of Articular Cartilage in the Knee
|
N/A | |
Terminated |
NCT01410136 -
Chondrofix Osteochondral Allograft Prospective Study
|
N/A | |
Active, not recruiting |
NCT00885729 -
Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects
|
Phase 1 | |
Terminated |
NCT01246635 -
Smith & Nephew's European Trufit Study
|
N/A |