Clinical Trial: Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Open-label Multi-center Study to Demonstrate the Safety and Efficacy of Cells Sheet-Autologous Chondrocyte Implantation（CS-ACI）for the Treatment of Articular Cartilage Defe

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Yan Jin

Current Primary Outcome: Mean change from baseline in the MRI [ Time Frame: 3month,6 month, 12 months, 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in the Lysholm [ Time Frame: 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 [ Time Frame: 3month,6 month, 12 months, 24 months ]


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: September 24, 2012
Date Started: April 2012
Date Completion: June 2015
Last Updated: September 28, 2012
Last Verified: September 2012