Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure
- Conditions
- Chronic Ischaemic Heart Failure
- Interventions
- Drug: Granulocyte-colony stimulating factorProcedure: Percutaneous intracoronary injectionProcedure: Percutaneous intramyocardial injection
- Registration Number
- NCT00747708
- Lead Sponsor
- Barts & The London NHS Trust
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peripheral Granulocyte-colony stimulating factor Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection Percutaneous intracoronary injection Granulocyte-colony stimulating factor 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 Percutaneous intracoronary injection Percutaneous intracoronary 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 Percutaneous intramyocardial injection Percutaneous intramyocardial 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 intramyocardial injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route Percutaneous intramyocardial injection Granulocyte-colony stimulating factor 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
- Primary Outcome Measures
Name Time Method Change in global left ventricular ejection fraction 12 months
- Secondary Outcome Measures
Name Time Method Change in NT-proBNP 6 months Occurence of major adverse cardiac event 12 months Change in quality of life 12 months change in NYHA class 12 months
Trial Locations
- Locations (1)
London Chest Hospital, Barts and the London NHS Trust
🇬🇧London, United Kingdom