Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure (REGEN-IHD)

October 8, 2013 updated by: Anthony Mathur, Barts & The London NHS Trust

Randomised Control Trial to Compare the Effects of G-CSF and Autologous Bone Marrow Progenitor Cells Infusion on the Quality of Life and Left Ventricular Function in Patients With Heart Failure Secondary to Ischaemic Heart Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E2 9JX
        • London Chest Hospital, Barts and The London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral
Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection
Drug: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Other Names:
  • G-CSF
Experimental: 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
Drug: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Other Names:
  • G-CSF
Procedure: Percutaneous intracoronary injection
Bone marrow derived stem/progenitor cells or placebo infusion is delivered through an over-the-wire balloon catheter into the target coronary vessels using a stop-flow technique.
Experimental: 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
Drug: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Other Names:
  • G-CSF
Procedure: Percutaneous intramyocardial injection
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in global left ventricular ejection fraction
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life
Time Frame: 6 months
6 months
Occurence of major adverse cardiac event
Time Frame: 12 months
12 months
Change in quality of life
Time Frame: 12 months
12 months
Change in NT-proBNP
Time Frame: 6 months
6 months
change in NYHA class
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Investigators

  • Principal Investigator: Anthony Mathur, FRCP FESC Ph, Barts and The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/Q0603/13
  • 2005-002706-27 (EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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