Ischemic Dilated CardiomyopathyPhase 2NCT01720888
Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy
A Phase 2 study testing BM-MSCs in people with Ischemic Dilated Cardiomyopathy, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Despite the recent advances in medical and surgical treatment, heart failure resulting from ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Dilated Cardiomyopathy
- What is being tested?
- BM-MSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- Jul 2012to Dec 2015
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 35 to 75 years
- diagnosed to have ICM confirmed by previous coronary angiogram showing significant coronary artery disease >70% or history of previous myocardial infarction.
- myocardial infarction event occured 6 months or longer from time of screening.
- LV ejection fraction of ≤40% by echocardiogram or cardiac MRI.
Who cannot join
- Likelihood of heart failure from other causes such as idiopathic, infective or metabolic cardiomyopathy,valvular heart disease and pericardial disease.
- patients who had undergone a coronary artery bypass graft(CABG) procedure.
- patients who do not have any visible/significant myocardial scar.
- patients with any cardiovascular metallic implantation.
- any contraindication to bone marrow aspiration
- any contraindication to coronary contrast angiography and angioplasty.
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- any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV.
- any past history of neoplasia and primary haematological disease.
- any current, past or paroxysmal cardiac arrhythmias.
- renal impairment indicated by creatinine clearance of less than 30 ml/min.
- liver impairment indicated by serum alanine transferase level at 4 times greater than normal value.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Open Label Phase II Study Assessing the Efficacy of Intracoronary Autologous Mesenchymal Stem Cells in Patients With Ischemic Dilated Cardiomyopathy
Despite the recent advances in medical and surgical treatment, heart failure resulting from ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.
Read the detailed description
Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow. Experimental and clinical studies to date have shown that mesenchymal stem cells represent the most suitable cell type for regeneration therapy after myocardial infarction (MI). After injection into ischemic myocardium, bone marrow-derived MSC (BM-MSC) from various animal species can differentiate into multiple cell lineages, including endothelial cells and cardiomyocytes, thereby improving LV function.
In Malaysia we have previously demonstrated our capability in isolating and extracting MSC from a small volume of bone marrow aspirates.The isolation, expansion and feasibility of storage, transport and differentiation of human MSC for clinical application has been performed locally. The researchers used autologous BM-MSC, ex vivo expanded, on three patients with end-stage ischemic dilated cardiomyopathy who were on the heart transplant waiting list and each patient was injected with MSCs directly into the myocardium during open heart surgery. After twelve months, all patients remained alive and well with significant improvement in cardiac function, quality of life and other parameters including reduction of myocardial scar volume as seen from cardiac scans.
The same group of researchers further carried out a study on ten patients with severe dilated cardiomyopathy and refractory cardiac function despite maximum medical therapy to receive autologous BM-MSC implantation via intramyocardial or intracoronary route. All patients remained alive at 1 year while recorded significant improvements in LV ejection fraction and other LV parameters from baseline to 6 and 12 months. Reduction in scar was also noted in six of the patients by 12 months.
Following these results, this study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.
- Conditions
- Ischemic Dilated Cardiomyopathy
- Being tested
- BM-MSCs
- Keywords
- Autologous, Bone Marrow, Mesenchymal Stem Cells, Ischemic Dilated Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MSCsOther
Also called Bone marrow-derived mesenchymal stem cells implantation
Intracoronary implantation of bone marrow-derived mesencymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Maximal medical therapy | No intervention | Maximal medical therapy which comprises of optimal pharmacological therapy |
| Maximal medical therapy and BM-MSCs | Experimental | Autologous Bone marrrow-derived mesenchymal stem cells implantation Receives: Other: BM-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV ejection fraction as measured by echocardiogram and cardiac MRI after implantation
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (5)
Changes in functional status
Measured: 12 months
Improvement in other LV parameters as assessed by echocardiogram and cardiovascular magnetic resonance(CMR).
Measured: 1 months, 3 months, 6 months, 9 months, 12 months
Resolution of scar tissue volume/area on cardiac MRI
Measured: 6 months, 12 months.
Change in serum N Terminal-pro B type natriuretic peptide(NT-proBNP)level
Measured: 1 month, 6 months, 12 months
Freedom from major adverse cardiac events as defined by myocardial infarction, hospitalization for angina, myocardial infarction or heart failure, or death (all cause of mortality).
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Dilated CardiomyopathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Responsible party
- Principal investigator, Professor Dr Oteh Maskon, National University of Malaysia
- Investigators
- Oteh Maskon, MB Bch, Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720888
- Sponsor's protocol ID
- ERGS/1/2011/SKK/UKM/02/72
- Status last verified
- Apr 2015
- First submitted
- 1 Nov 2012
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Open Label Phase II Study Assessing the Efficacy of Intracoronary Autologous Mesenchymal Stem Cells in Patients With Ischemic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01720888
- Acronym / sponsor ID
- ERGS/1/2011/SKK/UKM/02/72
- Conditions
- Ischemic Dilated Cardiomyopathy
- Keywords
- Autologous, Bone Marrow, Mesenchymal Stem Cells, Ischemic Dilated Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Nov 2012 (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.
Despite the recent advances in medical and surgical treatment, heart failure resulting from ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.
Detailed description
Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow. Experimental and clinical studies to date have shown that mesenchymal stem cells represent the most suitable cell type for regeneration therapy after myocardial infarction (MI). After injection into ischemic myocardium, bone marrow-derived MSC (BM-MSC) from various animal species can differentiate into multiple cell lineages, including endothelial cells and cardiomyocytes, thereby improving LV function.
In Malaysia we have previously demonstrated our capability in isolating and extracting MSC from a small volume of bone marrow aspirates.The isolation, expansion and feasibility of storage, transport and differentiation of human MSC for clinical application has been performed locally. The researchers used autologous BM-MSC, ex vivo expanded, on three patients with end-stage ischemic dilated cardiomyopathy who were on the heart transplant waiting list and each patient was injected with MSCs directly into the myocardium during open heart surgery. After twelve months, all patients remained alive and well with significant improvement in cardiac function, quality of life and other parameters including reduction of myocardial scar volume as seen from cardiac scans.
The same group of researchers further carried out a study on ten patients with severe dilated cardiomyopathy and refractory cardiac function despite maximum medical therapy to receive autologous BM-MSC implantation via intramyocardial or intracoronary route. All patients remained alive at 1 year while recorded significant improvements in LV ejection fraction and other LV parameters from baseline to 6 and 12 months. Reduction in scar was also noted in six of the patients by 12 months.
Following these results, this study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal medical therapy | No intervention | –Maximal medical therapy which comprises of optimal pharmacological therapy |
| Maximal medical therapy and BM-MSCs | Experimental | Other: BM-MSCsAutologous Bone marrrow-derived mesenchymal stem cells implantation |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 35 to 75 years
- diagnosed to have ICM confirmed by previous coronary angiogram showing significant coronary artery disease >70% or history of previous myocardial infarction.
- myocardial infarction event occured 6 months or longer from time of screening.
- LV ejection fraction of ≤40% by echocardiogram or cardiac MRI.
Key exclusion criteria (11 listed)
- Likelihood of heart failure from other causes such as idiopathic, infective or metabolic cardiomyopathy,valvular heart disease and pericardial disease.
- patients who had undergone a coronary artery bypass graft(CABG) procedure.
- patients who do not have any visible/significant myocardial scar.
- patients with any cardiovascular metallic implantation.
- any contraindication to bone marrow aspiration
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 |
|---|---|---|
| BM-MSCsAlso: Bone marrow-derived mesenchymal stem cells implantationIntracoronary implantation of bone marrow-derived mesencymal stem cells | Other | Maximal medical therapy and BM-MSCs |
Primary outcome
Change in LV ejection fraction as measured by echocardiogram and cardiac MRI after implantation
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
5 secondary outcomes
Changes in functional status
Time frame: 12 months
Improvement in other LV parameters as assessed by echocardiogram and cardiovascular magnetic resonance(CMR).
Time frame: 1 months, 3 months, 6 months, 9 months, 12 months
Resolution of scar tissue volume/area on cardiac MRI
Time frame: 6 months, 12 months.
Change in serum N Terminal-pro B type natriuretic peptide(NT-proBNP)level
Time frame: 1 month, 6 months, 12 months
Freedom from major adverse cardiac events as defined by myocardial infarction, hospitalization for angina, myocardial infarction or heart failure, or death (all cause of mortality).
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
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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.
Oteh Maskon, MB Bch principal investigator
Universiti Kebangsaan Malaysia Medical Centre
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 BM-MSCs in people with Ischemic Dilated Cardiomyopathy, run by National University of Malaysia at 1 site in Malaysia.
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 4 inclusion and 11 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 16 Apr 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 Malaysia. 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 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?
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 LV ejection fraction as measured by echocardiogram and cardiac MRI after implantation (time frame: 1 month, 3 months, 6 months, 9 months, 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 16 Apr 2015.