The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes from baseline exogenous insulin dose at different time points post treatment
研究概览
简要总结
This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.
详细描述
To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
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
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Duration of disease less than 12 months from diagnosis
- •With the history of diabetic ketoacidosis
排除标准
- •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
Changes from baseline exogenous insulin dose at different time points post treatment
时间窗: 1 month, 3 months,6 months, 12 months, 24 months, 36 months
次要结局
- titres of islet antigen antibodies(1 month, 3 months, 6 months, 12 months,24 months, 36 months)
- HbA1c level(1 month, 3 months, 6 months, 12 months, 24 months, 36 months)
- C-peptide level(1 month, 3 months, 6 months, 12 months, 24 months, 36 months)
研究者
Dalong Zhu
Chief Physician, Professor, Director of Endocrinology Department
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School