Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure - Full Text View

Sponsored by:	Barts & The London NHS Trust
Information provided by:	Barts & The London NHS Trust
ClinicalTrials.gov Identifier:	NCT00747708

Purpose

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

Condition	Intervention	Phase
Chronic Ischaemic Heart Failure	Drug: Granulocyte-colony stimulating factor Procedure: Percutaneous intracoronary injection Procedure: Percutaneous intramyocardial injection	Phase II Phase III

MedlinePlus related topics: Heart Diseases Heart Failure

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:

Change in global left ventricular ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in regional wall motion score index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Occurence of major adverse cardiac event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
Study Start Date:	August 2005
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Peripheral: Experimental Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection	Drug: Granulocyte-colony stimulating factor 5 days subcutaneous injection
Intracoronary: Experimental 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	Drug: Granulocyte-colony stimulating factor 5 days subcutaneous injection Procedure: 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.
Intramyocardial: Experimental 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	Drug: Granulocyte-colony stimulating factor 5 days subcutaneous injection Procedure: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747708

Contacts

Contact: Anthony Mathur, MB BChir, FRCP, PhD

(44) 2089832216

regenerate@bartsandthelondon.nhs.uk

Locations

United Kingdom
London Chest Hospital, Barts and the London NHS Trust	Recruiting
London, United Kingdom, E2 9JX
Contact: Laura Roberts (44) 2089832216 regenerate@bartsandthelondon.nhs.uk
Principal Investigator: Anthony Mathur, MBBChir, MRCP, PhD
Sub-Investigator: Chia Yeo, BM BCh, MRCP

Sponsors and Collaborators

Barts & The London NHS Trust

More Information

Click here for more information about this study: REGENERATE-IHD This link exits the ClinicalTrials.gov site

Responsible Party:	Barts and the London NHS Trust ( Dr Anthony Mathur )
Study ID Numbers:	04/Q0603/13, 2005-002706-27 (EudraCT)
Study First Received:	September 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00747708
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barts & The London NHS Trust:

heart failure
coronary heart disease
adult stem cells
bone marrow progenitor cells
bone marrow stem cells

autologous
granulocyte-colony stimulating factor
left ventricular function
intracoronary injection
intramyocardial injection

Study placed in the following topic categories:

Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia

Neoplasm Metastasis
Quality of Life
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009