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

Yan Jin10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteochondritis Osteochondritis Dissecans Joint Diseases

Interventions

CS-ACIDRUG

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）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (3)

Xijing Hospital

Xi'an, China

RECRUITING

Tangdu Hospital

Xi'an, China

RECRUITING

Xi'An Honghui Hospital

Xi'an, China

RECRUITING

Outcomes

Primary Outcomes

Mean change from baseline in the MRI

Time frame: 3month,6 month, 12 months, 24 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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