NCT00730561已完成不适用
Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2:A Randomized Controlled Trial.
Hospital Universitario Dr. Jose E. Gonzalez2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in nerve conduction velocity
研究概览
简要总结
Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification.
排除标准
- •Patients older than 75 years
- •Hypercoagulable states
- •Cardiac ejection fraction < 30%
- •Active vasculopathy in brain, kidneys or heart
- •Neoplastic disease
- •Active infection
- •Diabetic ketoacidosis or hyperosmolar hyperglycemic state
- •Gangrene of the extremity requiring immediate surgery.
结局指标
主要结局
Change in nerve conduction velocity
时间窗: Three months
次要结局
未报告次要终点
研究者
研究点 (2)
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