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

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yan Jin
• Collaborators: Tang-Du Hospital; Xijing Hospital

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