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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteochondritis, Osteochondritis Dissecans, Joint Diseases

Intervention / Treatment
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* Drug: CS-ACI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-ACI<br>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. | Drug: CS-ACI<br>* 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）<br>* Other names: Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in the MRI |  | 3month,6 month, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage repair, Cartilage defects, cell sheet, Autologous chondrocyte implantation