Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in HbA1c values
研究概览
简要总结
This is a single-center, phase IIT clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus.
Twenty patients with insulin-dependent diabetes mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. The primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient).
- •Age: 18-70 years old;
- •History of diabetes mellitus >1 year;
- •Insulin-dependent and total daily insulin dose >20 units;
- •Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation >8% );
- •Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy, patients who need to receive kidney transplantation.
排除标准
- •Severe heart disease; 2) Severe mental disorders, poor compliance or alcohol abuse; 3) Active infection or with malignancy; 4) Weight greater than 25% of ideal weight; 5) Evidence of endogenous insulin secretion, such as type 2 diabetes; 6) Smoking; 7) During gestation or preparation for gestation.
结局指标
主要结局
Changes in HbA1c values
时间窗: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
Changes in HbA1c values of patients during the study period since baseline.
Changes in C-peptide
时间窗: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline.
Changes in insulin
时间窗: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
Changes in insulin (fasting insulin and post-stimulated insulin) of patients during the study period since baseline.
次要结局
- Number of severe hypoglycemic events(Data will be recorded every week after the surgery during the follow-up time of 12 months.)
- Change in the patient's daily insulin unit requirement(Data will be recorded every day after the surgery until insulin treatment stops during the follow-up time of 12 months.)
- Changes in glucagon(before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total)