Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure (REGEN-IHD)
2013年10月8日 更新者：Anthony Mathur、Barts & The London NHS Trust
Randomised Control Trial to Compare the Effects of G-CSF and Autologous Bone Marrow Progenitor Cells Infusion on the Quality of Life and Left Ventricular Function in Patients With Heart Failure Secondary to Ischaemic Heart Disease
The purpose of this study is to determine whether adult bone marrow derived stem/progenitor cells improve cardiac function and symptoms in patients with heart failure and to establish the optimal method of delivery of these cells.
Study hypotheses:
- Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34+ positive cell counts
- Cardiac function and symptoms will improve in patients in whom the peripheral CD34+ counts increase in response to G-CSF administration
- Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
- Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
研究概览
地位
完全的
详细说明
The study involves three arms that compare the method of autologous bone marrow cel administration in patients with chronic heart failure. Each arm has a comparative group that contains either saline injection (peripheral arm that injects GCSF alone) or serum (the two interventional arms-intracoronary and intramyocardial injection).
The protocol (on the advice of the ethics committee) is divided into a 58 patients pilot study followed by recruitment into the intramyocardial arm (30 patients randomised 1:1 cells in serum vs serum alone) and then recruitment into the intracoronary and peripheral arms (30 patients randomised 1:1 cells in serum vs serum alone in each arm).
The study has been powered around the use of advanced imaging to measure within group changes in ejection fraction at 12 months as the primary end point.
研究类型
介入性
注册 (实际的)
148
阶段
- 阶段2
- 第三阶段
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
-
-
-
London、英国、E2 9JX
- London Chest Hospital, Barts and The London NHS Trust
-
-
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 及以上 (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:
- Symptomatic patients with a diagnosis of heart failure secondary to ischaemic heart disease who are on optimal heart failure treatment and no further treatment options available
- Patient has been considered for an implantable defibrillator in keeping with NICE guidelines
Exclusion Criteria:
- Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
- The presence of cardiogenic shock
- The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
- Known severe pre-existent left ventricular dysfunction (ejection fraction < 10% prior to randomisation)
- Congenital cardiac disease
- Cardiomyopathy secondary to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia
- Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
- Contra-indication for bone marrow aspiration
- Known active infection
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) syphilis or HTLV
- Lifestyle with high risk for infection with HIV, HBV or HCV syphilis or HTLV
- Serum creatinine >200 umol/L
- Chronic inflammatory disease
- Serious known concomitant disease with a life expectancy of less than one year
- Follow-up impossible (no fixed abode, etc)
- Previous participation in this study
- Female subjects of childbearing potential
- Atrial fibrillation
- Patients who have responded to the implantation of a biventricular pacemaker
- Weight >140kg
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：随机化
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Peripheral
Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection
|
5 days subcutaneous injection
其他名称：
|
|
实验性的：Percutaneous intracoronary injection
All patients will receive granulocyte-colony stimulating factor injections followed by a bone marrow aspiration.
Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
|
5 days subcutaneous injection
其他名称：
Bone marrow derived stem/progenitor cells or placebo infusion is delivered through an over-the-wire balloon catheter into the target coronary vessels using a stop-flow technique.
|
|
实验性的：Percutaneous intramyocardial injection
All patients will receive granulocyte-colony stimulating factor injections followed by a bone marrow aspiration.
Patients will be randomised in a 1:1 ratio to receive intramyocardial injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
|
5 days subcutaneous injection
其他名称：
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in global left ventricular ejection fraction
大体时间：12 months
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in quality of life
大体时间：6 months
|
6 months
|
|
Occurence of major adverse cardiac event
大体时间：12 months
|
12 months
|
|
Change in quality of life
大体时间：12 months
|
12 months
|
|
Change in NT-proBNP
大体时间：6 months
|
6 months
|
|
change in NYHA class
大体时间：12 months
|
12 months
|
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：Anthony Mathur, FRCP FESC Ph、Barts and the London NHS Trust
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。
研究主要日期
学习开始
2005年8月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2008年9月4日
首先提交符合 QC 标准的
2008年9月4日
首次发布 (估计)
2008年9月5日
研究记录更新
最后更新发布 (估计)
2013年10月9日
上次提交的符合 QC 标准的更新
2013年10月8日
最后验证
2013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.