Coronary Artery DiseasePhase 2END-HFNCT01150175
Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure
A Phase 2 study testing Endomyocardial Injection of Autologous Bone Marrow Cells and Endomyocardial Injection of Plasma in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Endomyocardial Injection of Autologous Bone Marrow Cells and Endomyocardial Injection of Plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Dec 2011
- Phase
- Phase 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
- Age 18-80 years old
- Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms
- Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
- Not suitable for conventional revascularization by their referring cardiologist.
- LVEF <40% by echocardiography.
- Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of CAD that is not amenable to standard revascularization procedures.
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- creatinine less than 250mmol/L, normal liver function, and normal blood count: WBC, granulocytes; platelet count, Hb.
- Reversible perfusion defect on single photon emission computed tomography (SPECT)
- Able to walk on treadmill
- Hemodynamically stable
- Subject is willing to comply with specified follow-up evaluations.
- All patients give written informed consent.
Who cannot join
- Atrial fibrillation
- History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation
- Severe valve disease
- Aortic or mitral valve prosthesis
- History of cancer in last 5 years
- Acute or chronic active sepsis, including HIV positive; hepatitis B or C positive
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- Left ventricular wall thickness less than 8 mm in the target territory
- Left ventricular thrombus and/or spontaneous echo-contrast in the LV detected by echocardiography or LV aneurysm
- Severe aorto-femoral-iliac disease
- Recent heart attack within the last 30 days
- Hypertrophic or restrictive cardiomyopathy
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Prof. HF Tse
Hong Kong
Teguh Santoso, PhD, 31930371, tsantoso@cbn.net.id
Thambar Sukumaran, PhD
About this study
Official title: Double-blind Placebo Controlled Trial on Direct Endomyocardial Injection of Autologous Bone Marrow Cells for Enhancement of Neovascularization in Patients With Ischaemic Heart Failure (END-HF)
The purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.
Read the detailed description
Coronary artery disease (CAD) remains to be one of the leading causes of mortality and morbidity worldwide. Despite the optimal use of anti-anginal medications and coronary revascularization, a large number of patients with CAD suffer from severe symptoms with disabling angina and heart failure (HF). Experimental and pilot clinical studies provided evidence of the safety and potential efficacy of a strategy of intramyocardial transplantation of autologous bone marrow (BM) cells for neovascularisation of chronically ischemic myocardium. Nevertheless, the possible potent placebo effect on symptoms observed in these pilot studies highlights the need for a randomized, placebo-controlled group to prove the clinical efficacy of cell based angiogenic therapy for treatment of severe CAD.
- Conditions
- Coronary Artery Disease
- Being tested
- Endomyocardial Injection of Autologous Bone Marrow Cells, Endomyocardial Injection of Plasma
- Keywords
- END-HF
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomyocardial Injection of Autologous Bone Marrow CellsProcedure or surgery
Also called END-HF
Endomyocardial Injection of Autologous Bone Marrow Cells
Endomyocardial Injection of PlasmaProcedure or surgery
Also called END-HF
Endomyocardial Injection of Plasma
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow cells | Experimental | Not described Receives: Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells |
| Plasma | Placebo comparator | Not described Receives: Procedure: Endomyocardial Injection of Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI ejection fraction
Measured: MRI ejection fraction changed from baseline to 6 months
Secondary outcomes (1)
Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150175
- Sponsor's protocol ID
- HKCTR-763
- Other IDs
- END-HF Version 1:17-5-08
- Acronym
- END-HF
- Status last verified
- Jun 2010
- First submitted
- 24 May 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Trial on Direct Endomyocardial Injection of Autologous Bone Marrow Cells for Enhancement of Neovascularization in Patients With Ischaemic Heart Failure (END-HF)
- ClinicalTrials.gov ID
- NCT01150175
- Acronym / sponsor ID
- END-HF / HKCTR-763
- Conditions
- Coronary Artery Disease
- Keywords
- END-HF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 Jun 2010 (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 direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.
Detailed description
Coronary artery disease (CAD) remains to be one of the leading causes of mortality and morbidity worldwide. Despite the optimal use of anti-anginal medications and coronary revascularization, a large number of patients with CAD suffer from severe symptoms with disabling angina and heart failure (HF). Experimental and pilot clinical studies provided evidence of the safety and potential efficacy of a strategy of intramyocardial transplantation of autologous bone marrow (BM) cells for neovascularisation of chronically ischemic myocardium. Nevertheless, the possible potent placebo effect on symptoms observed in these pilot studies highlights the need for a randomized, placebo-controlled group to prove the clinical efficacy of cell based angiogenic therapy for treatment of severe CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow cells | Experimental | Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells |
| Plasma | Placebo comparator | Procedure: Endomyocardial Injection of Plasma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-80 years old
- Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms
- Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
- Not suitable for conventional revascularization by their referring cardiologist.
- LVEF <40% by echocardiography.
Key exclusion criteria (12 listed)
- Atrial fibrillation
- History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation
- Severe valve disease
- Aortic or mitral valve prosthesis
- History of cancer in last 5 years
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 |
|---|---|---|
| Endomyocardial Injection of Autologous Bone Marrow CellsAlso: END-HFEndomyocardial Injection of Autologous Bone Marrow Cells | Procedure or surgery | Autologous bone marrow cells |
| Endomyocardial Injection of PlasmaAlso: END-HFEndomyocardial Injection of Plasma | Procedure or surgery | Plasma |
Primary outcome
MRI ejection fraction
Time frame: MRI ejection fraction changed from baseline to 6 months
1 secondary outcome
Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endomyocardial Injection of Autologous Bone Marrow Cells and Endomyocardial Injection of Plasma in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in China.
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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Jun 2010. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI ejection fraction (time frame: MRI ejection fraction changed from baseline to 6 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 24 Jun 2010.