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| Name | Class |
|---|---|
| Xijing Hospital | OTHER |
| Tang-Du Hospital | OTHER |
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In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.
All procedures are carried out after obtaining informed written consent from patients. Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are isolated and grown in culture for 6-8 weeks. After this time interval, the cells are reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the Cartilage defect of the keen.The patients will be assessed clinically with scoring systems preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-ACI | Experimental | Group/Cohort Label: pretherapy post-treatment Group/Cohort Description :The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-ACI | Drug | Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names: Cells Sheet-Autologous Chondrocyte Implantation (CS-ACI) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the MRI | 3month,6 month, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Lysholm | 3month,6 month, 12 months, 24 months | |
| Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport | 3month,6 month, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Yan, Ph.D | Research and Development Center for Tissue Engineering,Fourth Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22369960 | Background | Ebihara G, Sato M, Yamato M, Mitani G, Kutsuna T, Nagai T, Ito S, Ukai T, Kobayashi M, Kokubo M, Okano T, Mochida J. Cartilage repair in transplanted scaffold-free chondrocyte sheets using a minipig model. Biomaterials. 2012 May;33(15):3846-51. doi: 10.1016/j.biomaterials.2012.01.056. Epub 2012 Feb 25. |
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| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D010008 | Osteochondritis Dissecans |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002357 | Cartilage Diseases |
| D003240 | Connective Tissue Diseases |
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| Tangdu Hospital | Recruiting | Xi'an | 710038 | China |
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| Xi'An Honghui Hospital | Recruiting | Xi'an | 710054 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |