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临床试验/NCT00821470
NCT00821470已完成1 期

Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study

Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 1999年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
WOMAC Score

研究概览

简要总结

Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. Core decompression of the hip is the most widespread procedure used to treat early stage ON of the femoral head. Notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with ON of the femoral head (9). The investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with ON of the femoral head (10). This finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ARCO stage 1 or 2 osteonecrosis of the femoral head

排除标准

  • The investigators excluded patients with evidence of a malignant disorder during the past five years.

结局指标

主要结局

WOMAC Score

时间窗: 60 months

次要结局

  • Disease progression defined as progression to a fractural stage of osteonecrosis(60 months)

研究者

发起方
Erasme University Hospital
申办方类型
Other

研究点 (2)

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