Heart FailurePhase 1/2NCT00285454
Cell Repair in Heart Failure
A Phase 1/2 study testing Retrograde coronary venous delivery of cells. in people with Heart Failure and Ischemia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart muscle means that it functions inefficiently, and leads to symptoms of shortness of breath, chest pain and excess fluid in the body. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Ischemia
- What is being tested?
- Retrograde coronary venous delivery of cells.
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic ischaemic multi-vessel coronary artery disease (CAD) not suitable for standard revascularization procedures such as CABG, PCI, LVAD, or heart transplant.
- Area of reversible inducible ischaemia (>10% of LV on SPECT) performed not more than six months prior to study treatment.
- LVEF < 45% on optimal medical therapy.
- NYHA class II- IV patient stable on optimal medical therapy for at least 30 days.
- Written informed consent and agree to attend hospital appointments for 1 year.
- Male and females 18 to 80 years of age.
Who cannot join
- Left ventricular aneurysm or thrombus.
- Thoracic aortic aneurysm.
- Congenital Heart disease
- Acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
- Contraindication to MRI or any other study procedure.
- Presence or history of cancer (except low grade and fully resolved non-melanoma skin malignancy).
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- Any co-morbidity likely to reduce short- term survival or which may interfere with functional testing.
- Recent myocardial infarction < 6mths.
- Cerebral vascular accident < 6mths.
- Active hepatitis, receiving immunosuppressive therapy, undergoing haemodialysis.
- Clinically significant abnormal haematology.
- Recent history of alcoholism, drug abuse, or severe emotional, behavioural, or psychiatric problems.
- Fertile women who are pregnant, nursing, or using no form of contraception.
- Receiving experimental medications or participating in another study within 12 weeks of enrolment into this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Department of Gene Therapy, The National Heart and Lung Institute, Imperial College London and The Royal Brompton Hospital.
London, Middlesex, SW3 6LR
About this study
Official title: A Phase I/II, Randomised, Double-blind, Placebo Controlled, Single-centre Study of Bone Marrow Mononuclear Cells by Percutaneous Retrograde Coronary Venous Delivery to Patients With Ischaemic Heart Failure and no Standard Revascularisation Options.
Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart muscle means that it functions inefficiently, and leads to symptoms of shortness of breath, chest pain and excess fluid in the body. Recently it has been shown that cells from the inside of bone are able to produce many different cell types. We are investigating a new treatment in which a patient's bone marrow cells are taken, and injected into the heart in an attempt to produce new blood vessels and heart muscle cells. This may lead to a new treatment for ischaemic heart disease.
Read the detailed description
Study Objectives:
- Evaluate the safety of a single administration of bone marrow mononuclear cells by retrograde coronary venous delivery.
- Evaluate the bioactivity of bone marrow mononuclear cells in mediating increased perfusion in viable underperfused areas of myocardium.
- Evaluate the ability of bone marrow mononuclear cells to improve myocardial function specifically regional wall motion and cardiac synchronisation.
- Evaluate the use of potential bioactivity assays and clinical outcomes for assessing bone marrow mononuclear cell- induced myocardial changes.
Study Design:
A phase I/II, randomised, double-blind, placebo controlled, single-centre study of bone marrow mononuclear cells by percutaneous retrograde coronary venous delivery to patients with ischaemic heart failure and no standard revascularisation options.
Study Population:
Patients with symptomatic ischaemic heart failure, not amenable to conventional revascularisation strategies (PCI, CABG, LVAD) or transplantation.
Independent Eligibility:
The results of the screening procedures will be compiled and submitted to an independent interventional cardiologist and cardiac surgeon who are not associated with the study for consideration for enrolment. It will be the independent reviewer's responsibility to confirm eligibility prior to a patient participating in the study.
Product:
Autologous bone marrow mononuclear, the first 6 safety and feasibility patients (open-labelled) will receive a sub-population of Indium-111 labelled cells to assess feasibility of delivery. The remaining patients will either receive Active: Bone marrow mononuclear cells and 5 % HSA Placebo: 5% HSA
Route:
Retrograde coronary venous delivery The total dose of bone marrow mononuclear cells or placebo will be divided into two, each administered as a 10ml bolus into a selective coronary veins. There will be significant patient heterogeneity regarding size of ischaemic viable territory present and anatomy of venous system. We aim to treat two veins, individual SPECT and venogram results will be used to direct the venous anatomy to be targeted. An attempt will be made to cover as large an area as possible of a patient's ischaemic viable territory. The total dose of cells will remain constant between patients.
Safety:
The first 6 patients will receive cells as an adjunct to Cardiac resynchronization Therapy and ICD. An external Data Safety and Monitoring Board has also been appointed to oversee this study.
- Conditions
- Heart Failure, Ischemia
- Being tested
- Retrograde coronary venous delivery of cells.
- Medical subject headings
- Heart Failure, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde coronary venous delivery of cells.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: up to one year
Efficacy
Co-primary endpoints at 180 Days
Perfusion (MIBI SPECT)
Function (CMR)
Secondary outcomes (5)
Efficacy: at 180 days
Perfusion (CMR)
Function (ECHO, SPECT)
Exercise (VO2 Max)
QOL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2006 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Investigators
- Eric WF Alton, Principal investigator, The Department of Gene Therapy, The NHLI Imperial College LondonJonathan R Clague, Principal investigator, The Royal Brompton Hospital London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285454
- Sponsor's protocol ID
- Amanda Heinl-Green
- Status last verified
- Mar 2015
- First submitted
- 27 Jan 2006
- Last updated
- 31 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomised, Double-blind, Placebo Controlled, Single-centre Study of Bone Marrow Mononuclear Cells by Percutaneous Retrograde Coronary Venous Delivery to Patients With Ischaemic Heart Failure and no Standard Revascularisation Options.
- ClinicalTrials.gov ID
- NCT00285454
- Acronym / sponsor ID
- Amanda Heinl-Green
- Conditions
- Heart Failure, Ischemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2006 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 2 Feb 2006 (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.
Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart muscle means that it functions inefficiently, and leads to symptoms of shortness of breath, chest pain and excess fluid in the body. Recently it has been shown that cells from the inside of bone are able to produce many different cell types. We are investigating a new treatment in which a patient's bone marrow cells are taken, and injected into the heart in an attempt to produce new blood vessels and heart muscle cells. This may lead to a new treatment for ischaemic heart disease.
Detailed description
Study Objectives:
- Evaluate the safety of a single administration of bone marrow mononuclear cells by retrograde coronary venous delivery.
- Evaluate the bioactivity of bone marrow mononuclear cells in mediating increased perfusion in viable underperfused areas of myocardium.
- Evaluate the ability of bone marrow mononuclear cells to improve myocardial function specifically regional wall motion and cardiac synchronisation.
- Evaluate the use of potential bioactivity assays and clinical outcomes for assessing bone marrow mononuclear cell- induced myocardial changes.
Study Design:
A phase I/II, randomised, double-blind, placebo controlled, single-centre study of bone marrow mononuclear cells by percutaneous retrograde coronary venous delivery to patients with ischaemic heart failure and no standard revascularisation options.
Study Population:
Patients with symptomatic ischaemic heart failure, not amenable to conventional revascularisation strategies (PCI, CABG, LVAD) or transplantation.
Independent Eligibility:
The results of the screening procedures will be compiled and submitted to an independent interventional cardiologist and cardiac surgeon who are not associated with the study for consideration for enrolment. It will be the independent reviewer's responsibility to confirm eligibility prior to a patient participating in the study.
Product:
Autologous bone marrow mononuclear, the first 6 safety and feasibility patients (open-labelled) will receive a sub-population of Indium-111 labelled cells to assess feasibility of delivery. The remaining patients will either receive Active: Bone marrow mononuclear cells and 5 % HSA Placebo: 5% HSA
Route:
Retrograde coronary venous delivery The total dose of bone marrow mononuclear cells or placebo will be divided into two, each administered as a 10ml bolus into a selective coronary veins. There will be significant patient heterogeneity regarding size of ischaemic viable territory present and anatomy of venous system. We aim to treat two veins, individual SPECT and venogram results will be used to direct the venous anatomy to be targeted. An attempt will be made to cover as large an area as possible of a patient's ischaemic viable territory. The total dose of cells will remain constant between patients.
Safety:
The first 6 patients will receive cells as an adjunct to Cardiac resynchronization Therapy and ICD. An external Data Safety and Monitoring Board has also been appointed to oversee this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic ischaemic multi-vessel coronary artery disease (CAD) not suitable for standard revascularization procedures such as CABG, PCI, LVAD, or heart transplant.
- Area of reversible inducible ischaemia (>10% of LV on SPECT) performed not more than six months prior to study treatment.
- LVEF < 45% on optimal medical therapy.
- NYHA class II- IV patient stable on optimal medical therapy for at least 30 days.
- Written informed consent and agree to attend hospital appointments for 1 year.
Key exclusion criteria (14 listed)
- Left ventricular aneurysm or thrombus.
- Thoracic aortic aneurysm.
- Congenital Heart disease
- Acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
- Contraindication to MRI or any other study procedure.
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 |
|---|---|---|
| Retrograde coronary venous delivery of cells. | Procedure or surgery | – |
Primary outcome
Safety: up to one year
Efficacy
Co-primary endpoints at 180 Days
Perfusion (MIBI SPECT)
Function (CMR)
5 secondary outcomes
Efficacy: at 180 days
Perfusion (CMR)
Function (ECHO, SPECT)
Exercise (VO2 Max)
QOL
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Eric WF Alton principal investigator
The Department of Gene Therapy, The NHLI Imperial College London
Jonathan R Clague principal investigator
The Royal Brompton Hospital London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Retrograde coronary venous delivery of cells. in people with Heart Failure and Ischemia, run by Imperial College London 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 31 Mar 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety: up to one year. The study lists 5 primary outcomes in all. 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 31 Mar 2015.