Myocardial InfarctionPhase 1REVITALIZENCT00874354
Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
A Phase 1 study testing Intracoronary Transplantation of Bone Marrow Stem Cells in people with Myocardial Infarction, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This research is being done because currently there is no effective way in regenerating or replacing the heart muscle that has been damaged after a heart attack. The purpose of this study is to test whether injecting cells obtained from the patient's bone marrow into the coronary artery can regenerate and replace… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Intracoronary Transplantation of Bone Marrow Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2013
- Phase
- Phase 1
- 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
- Patients with acute myocardial infarction (ST elevation in at least 2 leads ≥ 0.2 mV in V1,V2 or V3 or ≥ 0.1 mV in other leads), treated by one of the following procedures:
- Acute PCI with stent implantation for acute ST elevation MI for either denovo lesions or in-stent thrombosis
- Treatment with thrombolysis followed by PCI with stent implantation.
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
Show all 9Show fewer
- Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
- Age 18 - 80 Years
- Written informed consent
Who cannot join
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- Need to acutely revascularize additional vessels, outside the infarct artery.
- Arteriovenous malformations or aneurysms
- Active infection or fever or diarrhea within last 4 weeks.
- Chronic inflammatory disease
- HIV infection or active hepatitis
Show all 21Show fewer
- Neoplastic disease without documented remission within the past 5 years.
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1.5)
- Anemia (hemoglobin < 8.5 g/dl)
- Platelet count < 100,000/µl
- Hypersplenism
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation
- Previously performed stem / mononuclear cell therapy
- Participation in another clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
This research is being done because currently there is no effective way in regenerating or replacing the heart muscle that has been damaged after a heart attack.
The purpose of this study is to test whether injecting cells obtained from the patient's bone marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart and prevent heart from dilating and developing heart failure.
Read the detailed description
The main objective of this study is to investigate the safety and clinical outcome of intracoronary infusion of autologous bone marrow cells in patients with myocardial infarction (MI). We hypothesize that patients treated with stem cell therapy will have beneficial effects on left ventricular (LV) remodeling and functional regeneration after MI and successful primary percutaneous coronary intervention (PCI) in setting of prospective randomized controlled trial.
Congestive heart failure (CHF), which is most commonly caused by acute myocardial infarction (AMI), is the most frequent cause of hospitalization in the United States in patients over the age of 65. Although current pharmacotherapy can inhibit neurohormonal activation, this falls short in preventing LV remodeling and the development of CHF. Stem cells are undifferentiated pluripotent cells that can be obtained from the patient and have the potential to proliferate and differentiation into cardiomyocytes. The majority of the data on stem cell transplantation comes from preclinical animal studies. Although the results are interesting and perhaps safe, early phase I clinical studies are small and are very preliminary. Data from large, randomized controlled trials are needed to clarify the short and long term effects of cellular cardiomyoplasty.
- Conditions
- Myocardial Infarction
- Being tested
- Intracoronary Transplantation of Bone Marrow Stem Cells
- Keywords
- Myocardial Infarction, Heart Attack, Infarct, Stem Cells, Bone Marrow Derived Mononuclear Cells, CHF, Congestive Heart Failure, Stent, PCI, Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Infarction, Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary Transplantation of Bone Marrow Stem CellsDrug
Also called REVITALIZE
Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Patients within 3 to 14 days from percutaneous coronary intervention (PCI) and stent implantation for Acute Myocardial Infarction (AMI) will receive either 50 cc's or 100 cc's of autologous bone marrow mononuclear cells through an intracoronary tranplantation of stem cells into the infarct-related coronary artery. Receives: Drug: Intracoronary Transplantation of Bone Marrow Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of intracoronary administration of autologous bone marrow-derived mononuclear cells; Improvement of global left ventricular ejection fraction by cardiac MRI and echocardiography after 4 months.
Measured: 4 months from procedure
Secondary outcomes (1)
Freedom from Major Adverse Cardiac Event (MACE)
Measured: 12 months from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJul 2005
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Makkar, Cedars-Sinai Medical Center
- Investigators
- Raj Makkar, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874354
- Sponsor's protocol ID
- 4441
- Acronym
- REVITALIZE
- Status last verified
- Feb 2017
- First submitted
- 26 Dec 2007
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00874354
- Acronym / sponsor ID
- REVITALIZE / 4441
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Heart Attack, Infarct, Stem Cells, Bone Marrow Derived Mononuclear Cells, CHF, Congestive Heart Failure, Stent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Apr 2009 (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 research is being done because currently there is no effective way in regenerating or replacing the heart muscle that has been damaged after a heart attack.
The purpose of this study is to test whether injecting cells obtained from the patient's bone marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart and prevent heart from dilating and developing heart failure.
Detailed description
The main objective of this study is to investigate the safety and clinical outcome of intracoronary infusion of autologous bone marrow cells in patients with myocardial infarction (MI). We hypothesize that patients treated with stem cell therapy will have beneficial effects on left ventricular (LV) remodeling and functional regeneration after MI and successful primary percutaneous coronary intervention (PCI) in setting of prospective randomized controlled trial.
Congestive heart failure (CHF), which is most commonly caused by acute myocardial infarction (AMI), is the most frequent cause of hospitalization in the United States in patients over the age of 65. Although current pharmacotherapy can inhibit neurohormonal activation, this falls short in preventing LV remodeling and the development of CHF. Stem cells are undifferentiated pluripotent cells that can be obtained from the patient and have the potential to proliferate and differentiation into cardiomyocytes. The majority of the data on stem cell transplantation comes from preclinical animal studies. Although the results are interesting and perhaps safe, early phase I clinical studies are small and are very preliminary. Data from large, randomized controlled trials are needed to clarify the short and long term effects of cellular cardiomyoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Drug: Intracoronary Transplantation of Bone Marrow Stem CellsPatients within 3 to 14 days from percutaneous coronary intervention (PCI) and stent implantation for Acute Myocardial Infarction (AMI) will receive either 50 cc's or 100 cc's of autologous bone marrow mononuclear cells through an intracoronary tranplantation of stem cells into the infarct-related coronary artery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with acute myocardial infarction (ST elevation in at least 2 leads ≥ 0.2 mV in V1,V2 or V3 or ≥ 0.1 mV in other leads), treated by one of the following procedures:
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
- Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
Key exclusion criteria (21 listed)
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- Need to acutely revascularize additional vessels, outside the infarct artery.
- Arteriovenous malformations or aneurysms
- Active infection or fever or diarrhea within last 4 weeks.
- Chronic inflammatory disease
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 |
|---|---|---|
| Intracoronary Transplantation of Bone Marrow Stem CellsAlso: REVITALIZEIntracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction. | Drug | Autologous bone marrow stem cells |
Primary outcome
Safety and feasibility of intracoronary administration of autologous bone marrow-derived mononuclear cells; Improvement of global left ventricular ejection fraction by cardiac MRI and echocardiography after 4 months.
Time frame: 4 months from procedure
1 secondary outcome
Freedom from Major Adverse Cardiac Event (MACE)
Time frame: 12 months from procedure
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 2 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Raj Makkar, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intracoronary Transplantation of Bone Marrow Stem Cells in people with Myocardial Infarction, run by Cedars-Sinai Medical Center at 1 site in United States.
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 9 inclusion and 21 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 2 Feb 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 United States. 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 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.
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?
Safety and feasibility of intracoronary administration of autologous bone marrow-derived mononuclear cells; Improvement of global left ventricular ejection fraction by cardiac MRI and echocardiography after 4 months. (time frame: 4 months from procedure). 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 2 Feb 2017.