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临床试验/NCT00813267
NCT00813267Unknown早期 1 期

Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head

Jianming Tan1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
早期 1 期
发起方
入组人数
15
试验地点
1
主要终点
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis

研究概览

简要总结

Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.

详细描述

Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.

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
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages: 12 to 60 years old.
  • Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
  • Able to give informed consent.

排除标准

  • Pregnant women.
  • Previous history of malignancy
  • Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
  • Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.
  • Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
  • Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.

结局指标

主要结局

The femoral head blood-supply artery angiographies and the areas of femoral head necrosis

时间窗: 2

次要结局

  • Coxa joint paining(2)
  • Walking distance(2)
  • Joint functions(2)
  • Life(2)

研究者

发起方
Jianming Tan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jianming Tan

Director

Fuzhou General Hospital

研究点 (1)

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