Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Absence of ophthalmic complications
研究概览
简要总结
The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.
详细描述
Investigators intend to transplant 4 Type 1 Diabetes mellitus patients with compromised vision in one or both eyes due to diabetic or other complications, and who have already received kidney transplantation (i.e., already on immunosuppression). Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with compromised vision. Since the recipients are already immunosuppressed due to maintenance therapy for the kidney graft, investigators will only use non-steroidal anti-inflammatory drug (NSAID).
Only in case of uncontrolled reaction, steroid should be used under guidance of the ophthalmologists. Investigators will neither inject local immunosuppressive drugs nor change ongoing immunosuppressive medication in the pilot study.
The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.
In this pilot study investigators aim to gain experience in the technique, to obtain preliminary data on the amount of insulin that can be expected per transplanted islet equivalent (IEQ) and observe possible local reactions. These data will help to design a future larger study in patients without visual impairment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes (American Diabetes Association criteria)
- •Kidney transplant recipient with ongoing immunosuppression
- •At least one eye with extensive loss of vision from hand motion to no light perception due to damage of retina or optic nerve
- •Age ≥ 18 years
- •Normal cornea with good visualization of the anterior segment
- •Patient not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation
排除标准
- •Uncontrolled diabetic retinopathy
- •Signs of current infection
- •Poor visualization of the anterior chamber
结局指标
主要结局
Absence of ophthalmic complications
时间窗: 90 days
safety
次要结局
- Change in total number of hypoglycemic events(90 days)
- Change in HbA1c(90 days)
- Change in insulin requirements(90 days)
- Change in insulin production(90 days)
- Change in fasting glucose(90 days)