NCT00821899已完成不适用
Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
研究概览
简要总结
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.
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
- •diabetes type 1 patients
- •18 to 50 years of age
- •more than 5 years of evolution of the disease
- •brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes
排除标准
- •history of cancer
- •hematologic alterations
- •infectious disease positivity (HIV, HCV etc.)
- •diabetic nephropathy
- •cardiac failure
- •liver disease
- •autoimmune systemic disease
- •allergy to iodine contrast or anesthesia
结局指标
主要结局
Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
时间窗: 12 months
次要结局
- Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.(12 months)
- Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.(12 months)
- Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.(12 months)
研究者
Enric Esmatjes
MD
Hospital Clinic of Barcelona
研究点 (4)
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