Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure

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.

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