Chronic Myocardial IschemiaPhase 2NCT01454323
Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
A Phase 2 study testing Bone marrow mononuclear cells in people with Chronic Myocardial Ischemia, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial summary
Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Myocardial Ischemia
- What is being tested?
- Bone marrow mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2010to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years.
- Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
- Left ventricular ejection fraction (LVEF)<45% and distensibility changes.
- Complete revascularization performed at least 6 months before infusion cells.
Who cannot join
- Patients in active waiting list for heart transplantation..
- Treatable patients with resynchronization.
- Patients over 80 years
- Coexistence of other serious systemic diseases.
- Active infection, HIV, Hepatitis B or Hepatitis C.
- Patients with malignant or pre-malignant tumours.
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- Coexistence of any haematological disease.
- Pregnant women, in breastfeeding period, or in childbearing potential age who are not using effective contraception.
- Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial on the Effect of Intracoronary Infusion of Bone Marrow Mononuclear Cells on Functional Recovery in Patients With Myocardial Chronic Back and Severely Depressed Left Ventricular Function.
Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition.
Included patients will be studied in the following conditions:
Read more
- Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
- Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
- Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
- Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function.
The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery
Read the detailed description
This is an uncontrolled study in which the efficacy of the cell therapy drug is measured by comparing the variables of ventricular function after treatment to the basal condition prior to its application
The total number of patients to be studied 20. The study population will correspond to male and female patients with chronic anterior myocardial infarction (more than 6 months after the acute episode) and ventricular dysfunction. It is expected 36 months of inclusion and one year follow up
Patients will receive in a concomitant way the drug treatment established by the good practice, so it would certainly be possible that some improvement occurs due to drug treatment.
It will be studied the patient population of both genders aged between 18 and 80 years diagnosed with Chronic anterior myocardial infarction (more than 6 months after the acute phase and the complete revascularization).
Objectives of the study:
- Main objective: To determine the efficacy of intracoronary injection of adult stem cells from autologous bone marrow in patients with chronic anterior myocardial infarction in terms of improvement of ventricular function, determined by hemodynamic, echocardiographic and New York Heart Association (NYHA) functional class criteria, resulting in an improvement of heart failure symptoms and quality of life's patient.
- Secondary objectives:
- To investigate the basic cellular mechanisms underlying the myocardial regeneration process through correlation between hemodynamic criteria for the ventricular function improvement and the biologicals corresponding to the composition and the functionality of the infused cells.
- To analyze clinical, hemodynamic and biologicals factors able to influence favorably to a greater degree of functional recovery after regenerative treatment in chronic myocardial infarction.
- To design, in view of the results obtained, suitable protocol for the application of cell therapy to treat patients with old anterior infarction, both in terms of the ideal characteristics of medullary graft as in terms of those patients more likely to be beneficiaries of it, in order to establish a definitive strategy of including cell therapy in the standard treatment of this disease in the near future provided that the results indicate it so.
The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.
- Conditions
- Chronic Myocardial Ischemia
- Being tested
- Bone marrow mononuclear cells
- Keywords
- Chronic Myocardial Ischemia, Cell therapy, Bone marrow mononuclear cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow mononuclear cellsOther
Intracoronary infusion of autologous bone marrow-derived mononuclear cells
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dose of bone marrow mononuclear cells: 5-7 x 108 total cells Receives: Other: Bone marrow mononuclear cells |
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: 3, 6 and 12 months after intervention
Secondary outcomes (2)
Major Adverse Cardiac Events (MACE)
Measured: 12 months
Functional grade of the New York Heart Association (NYHA)
Measured: 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myocardial IschemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Responsible party
- Sponsor
- Investigators
- Jose Suarez de lezo, MD, PhD, Study chair, University Hospital Reina Sofía, Córdoba.Inmaculada Herrera, MD, PhD, Study chair, University Hospital Reina Sofía, Córdoba.Miguel Ángel Romero, MD, Principal investigator, University Hospital Reina Sofía, Córdoba.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454323
- Sponsor's protocol ID
- CMMo/CIC/2009
- Other IDs
- 2009-016599-66, 2009
- Status last verified
- Nov 2014
- First submitted
- 12 Oct 2011
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial on the Effect of Intracoronary Infusion of Bone Marrow Mononuclear Cells on Functional Recovery in Patients With Myocardial Chronic Back and Severely Depressed Left Ventricular Function.
- ClinicalTrials.gov ID
- NCT01454323
- Acronym / sponsor ID
- CMMo/CIC/2009
- Conditions
- Chronic Myocardial Ischemia
- Keywords
- Chronic Myocardial Ischemia, Cell therapy, Bone marrow mononuclear cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Study start
- Dec 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Oct 2011 (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.
Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition.
Included patients will be studied in the following conditions:
- Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
- Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
- Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
- Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function.
The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery
Detailed description
This is an uncontrolled study in which the efficacy of the cell therapy drug is measured by comparing the variables of ventricular function after treatment to the basal condition prior to its application
The total number of patients to be studied 20. The study population will correspond to male and female patients with chronic anterior myocardial infarction (more than 6 months after the acute episode) and ventricular dysfunction. It is expected 36 months of inclusion and one year follow up
Patients will receive in a concomitant way the drug treatment established by the good practice, so it would certainly be possible that some improvement occurs due to drug treatment.
It will be studied the patient population of both genders aged between 18 and 80 years diagnosed with Chronic anterior myocardial infarction (more than 6 months after the acute phase and the complete revascularization).
Objectives of the study:
- Main objective: To determine the efficacy of intracoronary injection of adult stem cells from autologous bone marrow in patients with chronic anterior myocardial infarction in terms of improvement of ventricular function, determined by hemodynamic, echocardiographic and New York Heart Association (NYHA) functional class criteria, resulting in an improvement of heart failure symptoms and quality of life's patient.
- Secondary objectives:
- To investigate the basic cellular mechanisms underlying the myocardial regeneration process through correlation between hemodynamic criteria for the ventricular function improvement and the biologicals corresponding to the composition and the functionality of the infused cells.
- To analyze clinical, hemodynamic and biologicals factors able to influence favorably to a greater degree of functional recovery after regenerative treatment in chronic myocardial infarction.
- To design, in view of the results obtained, suitable protocol for the application of cell therapy to treat patients with old anterior infarction, both in terms of the ideal characteristics of medullary graft as in terms of those patients more likely to be beneficiaries of it, in order to establish a definitive strategy of including cell therapy in the standard treatment of this disease in the near future provided that the results indicate it so.
The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Bone marrow mononuclear cellsDose of bone marrow mononuclear cells: 5-7 x 108 total cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years.
- Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
- Left ventricular ejection fraction (LVEF)<45% and distensibility changes.
- Complete revascularization performed at least 6 months before infusion cells.
Key exclusion criteria (9 listed)
- Patients in active waiting list for heart transplantation..
- Treatable patients with resynchronization.
- Patients over 80 years
- Coexistence of other serious systemic diseases.
- Active infection, HIV, Hepatitis B or Hepatitis C.
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 |
|---|---|---|
| Bone marrow mononuclear cellsIntracoronary infusion of autologous bone marrow-derived mononuclear cells | Other | Intervention |
Primary outcome
Change from baseline in left ventricular ejection fraction (LVEF)
Time frame: 3, 6 and 12 months after intervention
2 secondary outcomes
Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Functional grade of the New York Heart Association (NYHA)
Time frame: 3,6 and 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 30 Jun 2015.
- Andalusian Molecular Biology and Regenerative Medicine CentreLink provided by the sponsor.
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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.
Jose Suarez de lezo, MD, PhD study chair
University Hospital Reina Sofía, Córdoba.
Inmaculada Herrera, MD, PhD study chair
University Hospital Reina Sofía, Córdoba.
Miguel Ángel Romero, MD principal investigator
University Hospital Reina Sofía, Córdoba.
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 Bone marrow mononuclear cells in people with Chronic Myocardial Ischemia, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
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 9 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 30 Jun 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 Spain. 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?
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) (time frame: 3, 6 and 12 months after intervention). 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 30 Jun 2015.