Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
研究概览
简要总结
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.
The primary objectives of the study are:
- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works
The Secondary objective of the study is:
- To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
详细描述
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
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
- •Male and female subjects
- •Age 18 to 70 years of age
- •Have insulin dependent Diabetes Mellitus Type 1
- •Are post-renal transplant on maintenance immunosuppression with stable renal function
- •HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness
排除标准
- •Weight more than 90 kg
- •Insulin requirement > 60 Units/day
- •Other (non-kidney) organ transplants except prior failed pancreatic graft.
- •Untreated or unstable proliferative diabetic retinopathy
- •Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
- •Active infection
- •Negative screen for Epstein-Barr virus (EBV)
- •Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- •History of Factor V Leiden mutation
- •Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) > 1.5
- •Severe co-existing cardiac disease
- •Persistent elevation of liver function tests at the time of study entry
- •Acute or chronic pancreatitis
- •Male subjects with elevation of prostate specific antigen
- •Pregnancy
- •Positive screen for polyoma (BK) virus
- •Untreated hyperlipidemia
- •Recent hemorrhagic stroke
- •Factors associated with an increased risk of bleeding
- •Contact PI for complete Incl-Excl criteria list.
研究组 & 干预措施
Islet transplant
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
干预措施: Purified Pancreatic Islets (Biological)
Islet transplant
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
干预措施: Etanercept (Drug)
结局指标
主要结局
Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
时间窗: 1 year after the subject's first islet transplant
次要结局
- Number of Participants With a Decrease of Severe Hypoglycemic Events(1 year after subject's first transplant)
- Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine(1 year after subjects initial islet transplant)
- Impact on Vision(1 year after the subject's first islet transplant)
- Improvement of Metabolic Control(1 year after the subject's first islet transplant)
- Reduction of Insulin Requriements(1 year after the subject's first islet transplant)
- An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction(1 year after the subject's first islet transplant)
- Number of Participants With a Decrease in HbA1c(1 year after subject's first islet transplant)
- Absence of Negative Renal Impact Measures(1 year after the subject's first islet transplant)
研究者
James F. Markmann, MD, PhD
Chief Division of Transplantation
Massachusetts General Hospital