Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Lowering of blood glucose be it fasting, random or post prandial
研究概览
简要总结
The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.
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 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then 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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Type II diabetes for at least 2 years
- •Type 2 diabetics on oral hypoglycemic agents and/or insulin
- •Fasting blood sugar of >200mg% on at least two occasions
- •Willing to keep a weekly diary and undergo observation for 12 months
排除标准
- •Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
结局指标
主要结局
Lowering of blood glucose be it fasting, random or post prandial
时间窗: At 2, 4, 12, 24, 36, and 48 weeks
次要结局
- Decrease in anti-hyperglycemic medication dosages.(At 2, 4, 12, 24, 36, and 48 weeks.)
- Improvement in the general well-being of patients.(At 2, 4, 12, 24, 36, and 48 weeks.)
- Lowering of glycosylated hemoglobin (HbA1C).(At 4, 12, 24, 36, and 48 weeks)