Back to results

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

Primary Purpose

Chronic Ischaemic Heart Failure

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Granulocyte-colony stimulating factor

Percutaneous intracoronary injection

Percutaneous intramyocardial injection

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Peripheral

Percutaneous intracoronary injection

Percutaneous intramyocardial injection

Arm Description

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

Outcomes

Primary Outcome Measures

Change in global left ventricular ejection fraction

Secondary Outcome Measures

Change in quality of life

Occurence of major adverse cardiac event

Change in quality of life

Change in NT-proBNP

change in NYHA class

Full Information

NCT ID

NCT00747708

First Posted

September 4, 2008

Last Updated

October 8, 2013

Sponsor

Barts & The London NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT00747708

Brief Title

Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure

Acronym

REGEN-IHD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Ischaemic Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peripheral

Arm Type

Experimental

Arm Description

Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection

Arm Title

Percutaneous intracoronary injection

Arm Type

Experimental

Arm Description

Arm Title

Percutaneous intramyocardial injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Granulocyte-colony stimulating factor

Other Intervention Name(s)

G-CSF

Intervention Description

5 days subcutaneous injection

Intervention Type

Procedure

Intervention Name(s)

Percutaneous intracoronary injection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Percutaneous intramyocardial injection

Intervention Description

Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system

Primary Outcome Measure Information:

Title

Change in global left ventricular ejection fraction

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in quality of life

Time Frame

6 months

Title

Occurence of major adverse cardiac event

Time Frame

12 months

Title

Change in quality of life

Time Frame

12 months

Title

Change in NT-proBNP

Time Frame

6 months

Title

change in NYHA class

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Mathur, FRCP FESC Ph

Organizational Affiliation

Barts and the London NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Chest Hospital, Barts and the London NHS Trust

City

London

ZIP/Postal Code

E2 9JX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure

We'll reach out to this number within 24 hrs