Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust
• Treatments: Lenograstim; Sargramostim

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