Ischemic CardiomyopathyPhase 1/2NCT01913886
Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
A Phase 1/2 study testing MSCs injection in people with Ischemic Cardiomyopathy, run by Alexandra Cristina Senegaglia at 1 site in Brazil.
Trial summary
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- MSCs injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Mar 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic coronary artery disease
- NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
- Ejection fraction between 35% and 55%.
- Stable medical therapy for at least one month
- Patients clinically treated with coronary angioplasty with or without intraluminal stent.
- Patients with surgical revascularization and without the possibility of new invasive intervention.
Who cannot join
- Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
- An active uncontrolled infection.
- Pregnancy.
- Mental disability.
- Terminal illnesses.
- Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
Show all 10Show fewer
- Life perspective by other diseases under 1 year.
- History of severe arrhythmias
- Renal dysfunction or against medication
- Inability to perform cardiac catheterization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Read the detailed description
Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- MSCs injection
- Keywords
- Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis
- Medical subject headings
- Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCs injectionProcedure or surgery
MSCs cells will be injected in two aliquots of 10 ml by catheterism
| Study group | Role | What they receive |
|---|---|---|
| MSCs injection | Experimental | Injection of autologous bone marrow-derived mesenchymal cells Receives: Procedure: MSCs injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
Measured: 3 months
Secondary outcomes (3)
Change in quality of life
Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: 3 months, 6 months, 12 months
Changes in exercise capacity
Measured: 1 year
Changes in plasma inflammatory markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Cristina Senegaglia
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Curitiba, Brazil, Fundação Araucária
- Responsible party
- Sponsor-investigator, Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
- Investigators
- Paulo Brofman, PhD, Principal investigator, Pontifícia Universidade Católica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913886
- Sponsor's protocol ID
- MSC_Isquemica
- Status last verified
- Sep 2016
- First submitted
- 30 Jul 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01913886
- Acronym / sponsor ID
- MSC_Isquemica
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandra Cristina SenegagliaUniversity, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Curitiba, Brazil, Fundação Araucária
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Aug 2013 (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.
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Detailed description
Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs injection | Experimental | Procedure: MSCs injectionInjection of autologous bone marrow-derived mesenchymal cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic coronary artery disease
- NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
- Ejection fraction between 35% and 55%.
- Stable medical therapy for at least one month
- Patients clinically treated with coronary angioplasty with or without intraluminal stent.
Key exclusion criteria (10 listed)
- Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
- An active uncontrolled infection.
- Pregnancy.
- Mental disability.
- Terminal illnesses.
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 |
|---|---|---|
| MSCs injectionMSCs cells will be injected in two aliquots of 10 ml by catheterism | Procedure or surgery | MSCs injection |
Primary outcome
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
Time frame: 3 months
3 secondary outcomes
Change in quality of life
Time frame: 3 months, 6 months, 12 months
Changes in exercise capacity
Time frame: 1 year
Changes in plasma inflammatory markers
Time frame: 6 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 13 Dec 2017.
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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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.
Paulo Brofman, PhD principal investigator
Pontifícia Universidade Católica do Paraná
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 MSCs injection in people with Ischemic Cardiomyopathy, run by Alexandra Cristina Senegaglia at 1 site in Brazil.
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 10 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 13 Dec 2017. 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 Brazil. 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 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 from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram. (time frame: 3 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 13 Dec 2017.