Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Lowering of insulin-dependence and anti-hyperglycemic medication dosages
研究概览
简要总结
The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.
详细描述
Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Type I diabetes for at least 2 years
- •Insulin-dependent
排除标准
- •Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
结局指标
主要结局
Lowering of insulin-dependence and anti-hyperglycemic medication dosages
时间窗: At 2, 4, 12, 24, 36, and 48 weeks
次要结局
- Lowering of glycosylated hemoglobin (HbA1C).(At 4, 12, 24, 36, and 48 weeks)
- Increased circulating C-Peptide levels(At 4, 12, 24, 36, and 48 weeks.)
- Increased general well-being of patients.(At 2, 4, 12, 24, 36, and 48 weeks.)
- No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.(At 2, 4, 12, 24, 36, and 48 weeks.)