Brief Title
Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy
Official Title
Randomised Controlled Trial to Compare the Effects of G-CSF (Granocyte™) and Autologous Bone Marrow Progenitor Cells on Quality of Life and Left Ventricular Function in Patients With Idiopathic Dilated Cardiomyopathy
Brief Summary
A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change in left ventricular ejection fraction as measured by cardiac magnetic resonance imaging or computerised tomography
Secondary Outcome
Change in: Concentrations of N-terminal prohormone of brain natriuretic peptide (cardiac enzyme)
Condition
Dilated Cardiomyopathy
Intervention
granulocyte colony stimulating factor (GCSF)
Study Arms / Comparison Groups
Peripheral
Description: Half the patients will be randomised to the non-interventional part of the trial. In this subgroup of patients will be randomised 1:1 to 5 day course of subcutaneous placebo injections or a 5 day course of G-CSF(Granocyte™) subcutaneous injections
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
August 2010
Completion Date
July 2013
Primary Completion Date
December 2012
Eligibility Criteria
Inclusion Criteria: - Symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA II-III) attending their local 'Heart Failure clinic' who are on optimal heart failure treatment, under supervision from their physician or heart failure nurse specialist, and have no other treatment options - Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition - Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated - Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines) Exclusion Criteria: - NYHA I - Referral hospitals most recent documented ejection fraction of >45% (any imaging modality) - 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 (with a documented ejection fraction of <10% from referral hospital) prior to randomisation - Congenital cardiac disease - Cardiomyopathy secondary to a reversible cause that has not been treated 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 - Previous cardiac surgery - Contra-indication for bone marrow aspiration - Known active infection - Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), HTLV or syphilis. - Chronic inflammatory disease requiring ongoing medication - Serious known concomitant disease with a life expectancy of less than one year - Follow-up impossible (no fixed abode, etc) - Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm) - Patients with renal impairment (Creatinine >200mmol/L) - Neoplastic disease without documented remission within the past 5 years - Weight>140kg - Subjects of childbearing potential
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Anthony Mathur, MD FRCP FESC, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01302171
Organization ID
2009-013112-12
Responsible Party
Principal Investigator
Study Sponsor
Barts & The London NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor
Anthony Mathur, MD FRCP FESC, Principal Investigator, Barts & The London NHS Trust
Verification Date
November 2013