Trial | NCT01694823  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    10
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.
Study Started
Apr 30
2012
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
Oct 01
2012
Estimate

Drug CS-ACI

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）

  • Other names: Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）

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.

Criteria 

Inclusion Criteria:

Male or female patients, age: between 18 and 50 years
Defect: isolated ICRS grade III or IV single defect chondral lesions on Articular Cartilage
Defect size: 2.5 to < 5 cm2 after debridement to healthy cartilage up to 6 mm in depth.
Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
Informed consent signed and dated by patient and Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
No ligament damage or ligament damage after reconstruction

Exclusion Criteria:

Patients younger than 18 years and older than 50 years.
Arthrofibrosis or Ankylosis
Arthritis
Obesity
Infectious diseases
the other cases of patients which Doctors determine not participate in the trial
No Results Posted