Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure
NCT ID: NCT00747708
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
148 participants
INTERVENTIONAL
2005-08-31
2013-05-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Peripheral
Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection
Granulocyte-colony stimulating factor
5 days subcutaneous injection
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
Granulocyte-colony stimulating factor
5 days subcutaneous injection
Percutaneous intracoronary injection
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.
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
Granulocyte-colony stimulating factor
5 days subcutaneous injection
Percutaneous intramyocardial injection
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system
Interventions
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Granulocyte-colony stimulating factor
5 days subcutaneous injection
Percutaneous intracoronary injection
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.
Percutaneous intramyocardial injection
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has been considered for an implantable defibrillator in keeping with NICE guidelines
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Anthony Mathur
Lead Cardiologist
Principal Investigators
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Anthony Mathur, FRCP FESC Ph
Role: PRINCIPAL_INVESTIGATOR
Barts and the London NHS Trust
Locations
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London Chest Hospital, Barts and the London NHS Trust
London, London, United Kingdom
Countries
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Other Identifiers
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2005-002706-27 (EudraCT)
Identifier Type: -
Identifier Source: secondary_id
04/Q0603/13
Identifier Type: -
Identifier Source: org_study_id