Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure (REGEN-IHD)
Chronic Ischaemic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Ischaemic Heart Failure focused on measuring 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
Eligibility 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
Sites / Locations
- London Chest Hospital, Barts and the London NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Peripheral
Percutaneous intracoronary injection
Percutaneous intramyocardial injection
Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo 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
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