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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Mean change from baseline in the MRI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients younger than 18 years and older than 50 years.
- •Arthrofibrosis or Ankylosis
- •Arthritis
- •Infectious diseases
- •the other cases of patients which Doctors determine not participate in the trial
研究组 & 干预措施
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.
干预措施: CS-ACI (Drug)
结局指标
主要结局
Mean change from baseline in the MRI
时间窗: 3month,6 month, 12 months, 24 months
次要结局
- 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)
研究者
Yan Jin
Director of Research and Development Center for Tissue Engineering
Air Force Military Medical University, China