NCT00315588已完成2 期
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Rodolfo Alejandro1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2000年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Insulin Independence.
研究概览
简要总结
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
详细描述
- To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;
- To eliminate the incidence of hypoglycemic coma and unawareness by islet cell transplantation;
- To assess long-term function of successful islet cell transplants;
- To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells.
- To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin.
- To assess the ability of exenatide to improve islet survival at time of islet 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 60 years of age.
- •Patients with type 1 diabetes mellitus.
- •Patients with a renal transplant that is more than 6 months old.
- •Patients with stable renal graft function for the preceding 6 months, i.e. no episodes of rejection and changes in serum creatinine no more than 0.5 mg/dl from baseline.
- •Patients who are taking tacrolimus, sirolimus +/- steroids for maintenance immunosuppression for at least 6 months and are tolerating levels satisfactory for islet transplantation without severe complications.
- •Patients with a body mass index (BMI) of less than or equal to 26.
排除标准
- •Stimulated or basal C-peptide > 0.3 ng/ml.
- •Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
- •Patients with proteinuria (albuminuria > 300 mg in 24 hours +/- protein) of new onset since kidney transplantation. If proteinuria or albuminuria is thought to originate from the native kidney(s) this will not be an exclusion criterion.
- •Patients with corrected creatinine clearance of less than
- •Patients weighing more than 80 kg.
- •Patients with a body mass index (BMI) of greater than
- •Insulin requirement > 1.0 U/kg/d.
- •Anemia (hemoglobin: males < 11.0 g/dl; females < 10.0 g/dl).
- •Abnormal liver function tests (consistently > 1.5 x normal range).
- •Unstable diabetic retinopathy.
- •Evidence of acute or chronic active Epstein-Barr virus (EBV) infection (IgM ≥ IgG). Patients will be eligible if serological testing becomes consistent with previous exposure (i.e. IgG > IgM).
- •Patients with history of malignancy or current malignancy other than non-melanomatous skin cancer, or finding of any lesions or symptoms during screening that are suspicious for malignancy, until properly investigated and ruled out.
- •Patients with elevation of prostate-specific antigen > 4 unless malignancy has been excluded.
- •Patients with unstable cardiovascular status.
- •Patients with active infections until adequately treated, unless treatment is not judged as necessary by the investigators (including, but not limited to, mild skin and nail fungal infections).
- •Patients with serological evidence of infection with HIV, human t cell lymphotropic virus 1 (HTLV 1), HTLV 2, or hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable).
- •Patients with history and/or serological evidence of hepatitis C (those patients with hepatitis C, already transplanted in this protocol will continue in this trial).
- •Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided).
- •Patients with active peptic ulcer disease, gallstones, hepatic hemangioma, or portal hypertension.
- •Patients who are pregnant or breastfeeding, or who intend to procreate.
- •Patients who are sexually active females who are not:
- •post-menopausal,
- •surgically sterile, or
- •using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices combined with spermicidal gel are acceptable; condoms used alone are not acceptable).
- •Active alcohol or substance abuse; smoking in the last 6 months.
- •Patients with evidence of sensitization, i.e. panel reactive antibody (PRA) testing greater than 20%.
- •Lack of updated immunizations per current Centers for Disease Control (CDC) guidelines, as well as immunization against hepatitis B, pneumococcus, and influenza (during season), unless medically contraindicated.
- •Patients with psychogenic factors, which are judged at psychological evaluation, which make it unsafe to undergo islet transplantation, or which preclude therapeutic compliance.
- •Patients with any condition or any circumstance that would make it unsafe to undergo an islet transplant.
研究组 & 干预措施
Islet Transplantation
Experimental
Islet Transplantation in subjects with a previous kidney transplant.
干预措施: Islet Transplantation (Drug)
结局指标
主要结局
Insulin Independence.
时间窗: 1 year
Number of Participants who Achieved Insulin Independence at 1 Year
次要结局
- Stimulated C-peptide Greater Than 0.5 ng/ml(1 year)
- Reduction of Insulin Requirements(1year)
- Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness(1 years)
研究者
Rodolfo Alejandro
Professor of Medicine
University of Miami
研究点 (1)
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