Islet Transplantation Using Campath-1H and Infliximab Induction
2009年10月1日 更新者:University of Alberta
Islet Transplantation in Type 1 Diabetic Patients Using Campath-1H and Infliximab Induction
Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in selected patients with inadequate glucose control despite insulin therapy.
However, the perennial hope that such an approach would result in long-term freedom from the need for exogenous insulin, with stabilization of the secondary complications of diabetes, has failed to materialize in practice.
The goal of the present study is therefore to improve the safety and efficacy of clinical islet-alone transplantation by minimizing dependence on calcineurin-inhibitor therapy - thereby avoiding potential nephrotoxicity, and furthermore improving success with single-donor islet infusions by avoiding all diabetogenic immunosuppression.
Campath-1H, combined with Infliximab induction therapy provides a unique opportunity to minimize dosing of maintenance long-term immunosuppression while further promoting islet engraftment.
研究概览
详细说明
This is a single-centre, prospective, open-label study in Type 1 diabetic participants receiving an islet cell transplant; all participants will receive Campath-1H + Infliximab induction therapy followed by sirolimus and ultra-low dose tacrolimus maintenance therapy.
The primary objective of this protocol is to assess the safety of this treatment regimen in adult Type 1 diabetic participants receiving their first islet transplant.
研究类型
介入性
注册
12
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Alberta
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Edmonton、Alberta、加拿大、T6G2C8
- University of Alberta - Clinical Islet Transplant Program
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- must have Type 1 diabetes mellitus for more than 5 years
- diabetes must be complicated by at least one of the following situations that persist despite intensive insulin management efforts. The complicating situations are (1) Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels of < 3.0 mmol/L; (2) Metabolic lability/instability, characterized by MAGE ≥ 11.0 mmol/L and wide swings in blood glucose despite optimal diabetes therapy; and (3) Despite efforts at optimal glucose control, progressive secondary complications of diabetes, including retinopathy, neuropathy, or nephropathy
Exclusion Criteria:
- Severe co-existing cardiac disease
- Active alcohol or substance abuse
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- Active infection including hepatitis C, hepatitis B, HIV, or TB
- Any history of or current malignancies except squamous or basal skin cancer
- BMI > 28 kg/m2 or body weight > 85 kg at screening visit
- Positive fasting C-peptide response on assessment (2 positive results)
- Creatinine clearance < 80 mL/min/1.73 m2
- Serum creatinine > 150 µmol/L
- Macroalbuminuria (urinary albumin excretion rate > 300 mg/24h)
- Baseline Hb < 105g/L in women, or < 130 g/L in men
- Baseline LFT's outside of normal range
- Untreated proliferative retinopathy
- Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast feeding
- Previous transplant, or evidence of sensitization on PRA
- Insulin requirement > 1.0 IU/kg/day
- HbA1C > 0.12
- Hyperlipidemia (fasting LDL cholesterol > 3.4 mmol/L, treated or untreated; and/or fasting triglycerides > 2.3 mmol/L)
- Under treatment for a medical condition requiring chronic use of steroids
- Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT INR > 1.5
- Untreated Addison's disease
- Untreated Celiac disease
- Untreated thyroid disease
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:A.M. James Shapiro, MD, PhD、University of Alberta
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究注册日期
首次提交
2005年9月12日
首先提交符合 QC 标准的
2005年9月12日
首次发布 (估计)
2005年9月15日
研究记录更新
最后更新发布 (估计)
2009年10月2日
上次提交的符合 QC 标准的更新
2009年10月1日
最后验证
2009年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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