NCT01143168Unknown1 期
A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 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
- Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
详细描述
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Free will taking part in the study and ability to provide written informed consent.
- •Confirmed diagnosis of type I diabetes for at least 2 years
- •Insulin-dependent.
- •Age 18-50 years, Male/Female.
- •FBG≥7.0 mmol/L, and HbAc1≥7％.
- •Not pregnant or nursing.
- •Negative pregnancy test.
- •Fertile patients will use effective contraception.
排除标准
- •Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- •Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- •Active infection requiring treatment.
- •Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
结局指标
主要结局
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
时间窗: 1 year
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
次要结局
- Serious adverse event frequency and severity(1 year)
研究者
研究点 (2)
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