Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AUC C-peptide levels during mixed meal tolerance test
研究概览
简要总结
Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.
详细描述
Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.
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
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
- •Less than 6 weeks from diagnosis
排除标准
- •Previous diabetic ketoacidosis
- •Pregnancy
- •Severe psychiatric disorder
- •Severe organic impairment (renal, hepatic, cardiac, pulmonary)
- •Active infectious disease
- •Previous or present neoplastic disease
结局指标
主要结局
AUC C-peptide levels during mixed meal tolerance test
时间窗: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)
Safety
时间窗: Every 6 months until death
The process of analyzing safety data is made daily based on clinical interview, frequent physical examination and general laboratory findings weekly from the first stem cell infusion until 60 months after the last infusion. Chest X-ray will be performed in days 100, 180, 270, 360 after the lest infusion and then every 6 months. Fecal occult blood, alpha pheto protein, beta-human chorionic gonadotropin, carcino-embrionary antigen, abdomen ultrasound will be performed in month 6 and 12 after the last infusion and then yearly.
次要结局
- Daily insulin use(Daily (course of study is 7 years))
- Hemoglobin A1C(3 months)
- Anti-GAD titres(Every 6 months)
- Immunologic reconstitution parameters(Yearly (course of study is 7 years))