Chronic Ischaemic Heart FailurePhase 2/3REGEN-IHDNCT00747708
Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure
A Phase 2/3 study testing Granulocyte-colony stimulating factor, Percutaneous intracoronary injection and Percutaneous intramyocardial injection in people with Chronic Ischaemic Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ischaemic Heart Failure
- What is being tested?
- Granulocyte-colony stimulating factor, Percutaneous intracoronary injection and Percutaneous intramyocardial injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to May 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London Chest Hospital, Barts and the London NHS Trust
London, London, E2 9JX
About this study
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
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
Read the 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.
- Conditions
- Chronic Ischaemic Heart Failure
- Being tested
- Granulocyte-colony stimulating factor, Percutaneous intracoronary injection, Percutaneous intramyocardial injection
- 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
- Medical subject headings
- Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte-colony stimulating factorDrug
Also called G-CSF
5 days subcutaneous injection
Percutaneous intracoronary injectionProcedure or surgery
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.
Percutaneous intramyocardial injectionProcedure or surgery
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system
| Study group | Role | What they receive |
|---|---|---|
| Peripheral | Experimental | Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection Receives: Drug: Granulocyte-colony stimulating factor |
| Percutaneous intracoronary injection | Experimental | 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 Receives: Drug: Granulocyte-colony stimulating factor; Procedure: Percutaneous intracoronary injection |
| Percutaneous intramyocardial injection | Experimental | 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 Receives: Drug: Granulocyte-colony stimulating factor; Procedure: Percutaneous intramyocardial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global left ventricular ejection fraction
Measured: 12 months
Secondary outcomes (5)
Change in quality of life
Measured: 6 months
Occurence of major adverse cardiac event
Measured: 12 months
Change in quality of life
Measured: 12 months
Change in NT-proBNP
Measured: 6 months
change in NYHA class
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startAug 2005
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischaemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Mathur, Barts & The London NHS Trust
- Investigators
- Anthony Mathur, FRCP FESC Ph, Principal investigator, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747708
- Sponsor's protocol ID
- 04/Q0603/13
- Other IDs
- 2005-002706-27 (EudraCT), 2005
- Acronym
- REGEN-IHD
- Status last verified
- Oct 2013
- First submitted
- 4 Sep 2008
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00747708
- Acronym / sponsor ID
- REGEN-IHD / 04/Q0603/13
- Conditions
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peripheral | Experimental | Drug: Granulocyte-colony stimulating factorPatients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection |
| Percutaneous intracoronary injection | Experimental | Drug: Granulocyte-colony stimulating factor, Procedure: Percutaneous intracoronary injectionAll 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 | Experimental | Drug: Granulocyte-colony stimulating factor, Procedure: Percutaneous intramyocardial injectionAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte-colony stimulating factorAlso: G-CSF5 days subcutaneous injection | Drug | Percutaneous intracoronary injection, Percutaneous intramyocardial injection, Peripheral |
| Percutaneous intracoronary injectionBone 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. | Procedure or surgery | Percutaneous intracoronary injection |
| Percutaneous intramyocardial injectionDirect intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system | Procedure or surgery | Percutaneous intramyocardial injection |
Primary outcome
Change in global left ventricular ejection fraction
Time frame: 12 months
5 secondary outcomes
Change in quality of life
Time frame: 6 months
Occurence of major adverse cardiac event
Time frame: 12 months
Change in quality of life
Time frame: 12 months
Change in NT-proBNP
Time frame: 6 months
change in NYHA class
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mathur, FRCP FESC Ph principal investigator
Barts and the London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Granulocyte-colony stimulating factor, Percutaneous intracoronary injection and Percutaneous intramyocardial injection in people with Chronic Ischaemic Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global left ventricular ejection fraction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.