NCT01142050Unknown1 期
A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus
Cellonis Biotechnology Co. Ltd.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.
详细描述
- To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
- To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Free will taking part in the study and ability to provide written informed consent;
- •Type 2 diabetes mellitus (as guideline WHO, 1999);
- •Age 18-75 years old，Male/Female;
- •19≤Body mass index (BMI)≤30㎏/㎡;
- •Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
- •Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
- •Not pregnant or nursing;
- •Negative pregnancy test;
- •Fertile patients will use effective contraception.
排除标准
- •Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
- •Active infection requiring treatment;
- •Unexplained febrile illness;
- •Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
结局指标
主要结局
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
时间窗: one year
1. Insulin resistance index indicated by ITT change compared with baseline. 2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline. 3. Hemoglobin A1c. 4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG). 5. C-peptide levels. 6. Serum Insulin levels.
次要结局
- Serious adverse event frequency and severity(one year)
研究者
研究点 (2)
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