Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Infections
研究概览
简要总结
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.
详细描述
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Patients are recruited from the waiting list for islet transplantation within The Nordic Network for Clinical Islet Transplantation. Patients included in the study will undergo apheresis while on the waiting list. T regulatory cells will be sorted out and frozen. Autologous, non modified T regs will then be infused simultaneously intraportally with the islet graft at transplantation. Patients will be followed for safety and efficacy regarding the islet transplantation over three months
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation
- •Type 1 diabetes with diagnosed <40years of age and with>5 years of exogenous insulin use
- •C peptide < 0.1 nmol/L at MMTT if no previous islet transplant
- •Adequate previous treatment by an experienced diabetologist
- •Patient must understand and be able to sign an informed consent
排除标准
- •Patient with a previous transplant other than islets
- •Patient with an BMI>30
- •Patient with an need of more than 1U/kg of insulin per 24h
- •Repeated abnormal liver function tests
- •non stable retinopathy
- •known abnormalities in coagulation
- •known malignancies
- •non stable heart conditions
- •active infections
- •serological proof of hepatitis B or C or HIV
- •signs of portal hypertension
- •patients that are pregnant, breast feeding or aim to become pregnant during the study period
- •patients with a PRA > 20%, positive cross match or known DSA
- •patients with conditions that the investigator would consider unsafe to combine with islet transplantation
结局指标
主要结局
Infections
时间窗: 0-90 days post transplantation
Number of treatment requiering infections in each patient during follow up
Thrombosis
时间窗: 0-75 days post transplant
Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later
Immunization
时间窗: 90 days post transplantation
Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline
Bleeding
时间窗: 0-1 days post transplant
Number of patients with \>20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1
Liver function
时间窗: 0-75days
Number of patients with an elevation of transaminases \> 5 times upper normal level during follow up
Islet graft failure
时间窗: day 75
Number of patients with islet graft failure shown as C peptide \<0.1 nmol/L fasting or \<0.3 nmol/L (90min) at a MMTT day 75 or lack of improvement compared to baseline if transplanted before.
次要结局
- Hypoglycemic unawareness(day 75)
- PRA level(day 90)
- HbA1c(day 75)
- HbA1c and hypoglycemic unawareness combined(day 75)
- Insulin independence(day 75)
- Islet function(day 75)