Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in insulin pancreatic reserve
研究概览
简要总结
The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.
详细描述
Aim: to evaluate whether a single intravenous administration of allogeneic bone marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified endogenous insulin secretion capacity and exogenous insulin requirement in patients with Type 1 Diabetes Mellitus.
Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with pancreatic reserve of insulin.
Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic MSCs.
Follow up: before and 1, 6, 24 months after MSC administration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •differential diagnosis of Type 1 Diabetes
- •diagnosed performed at most 1 year before enrollment
- •pancreatic reserve of insulin higher than 0.8 nmol/L/h
- •good general health status
- •informed consent of patient
- •consent of treating physician
- •proved psychiatric competence to be enrolled in a clinical study
排除标准
- •pregnancy
- •significant comorbidities
- •HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive
研究组 & 干预措施
DMT1+MSCs
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
干预措施: MSCs (Biological)
结局指标
主要结局
Changes in insulin pancreatic reserve
时间窗: pre- and 1, 6, 24 months post-intervention
Levels of insulin secreted after the acute ingestion of a protein rich liquid diet
次要结局
- Changes in insulin requirement(pre- and up to 24 months post-intervention)
研究者
Paulette Conget
Dr
Universidad del Desarrollo