跳至主要内容
临床试验/NCT00850187
NCT00850187已完成1 期

Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold

Royan Institute1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
6
试验地点
1
主要终点
Knee cartilage defects

研究概览

简要总结

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis

详细描述

Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.

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
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 to 60, inclusive
  • Normal axial alignment
  • Stable knee-previous ligament reconstruction, if stable
  • Intact articular cartilage in posterior meniscal weight-bearing zone
  • Ability to understand and willingness tosign consent from
  • O.C.D or OA calgran classification II,III

排除标准

  • Pregnant or lactating
  • Inflammatory arthritis
  • Oral steriod, methotrexate
  • Unable to follow post-operative exercise regimen or return for evaluations

结局指标

主要结局

Knee cartilage defects

时间窗: 12 months

次要结局

  • pain(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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