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

Phase 1

• Conditions: Osteochondritis; Osteochondritis Dissecans; Joint Diseases
• Interventions: Drug: CS-ACI

• Registration Number: NCT01694823
• Lead Sponsor: Yan Jin

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 Description

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 Timeline

• Study Start: 2012-04
• Status Verified: 2012-09
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-27
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01
• Primary Completion: 2013-07
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS-ACI	CS-ACI	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.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the MRI	3month,6 month, 12 months, 24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Xijing Hospital; 🇨🇳 Xi'an Shi, China

Tangdu Hospital; 🇨🇳 Xi'an Shi, China

Xi'An Honghui Hospital; 🇨🇳 Xi'an Shi, China