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Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction (REVITALIZE)

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intracoronary Transplantation of Bone Marrow Stem Cells

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Heart Attack, Infarct, Stem Cells, Bone Marrow Derived Mononuclear Cells, CHF, Congestive Heart Failure, Stent, PCI, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
Age 18 - 80 Years
Written informed consent

Exclusion Criteria:

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
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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous bone marrow stem cells

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Freedom from Major Adverse Cardiac Event (MACE)

Full Information

NCT ID

NCT00874354

First Posted

December 26, 2007

Last Updated

February 1, 2017

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00874354

Brief Title

Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

Acronym

REVITALIZE

Official Title

REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Myocardial Infarction, Heart Attack, Infarct, Stem Cells, Bone Marrow Derived Mononuclear Cells, CHF, Congestive Heart Failure, Stent, PCI, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous bone marrow stem cells

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intracoronary Transplantation of Bone Marrow Stem Cells

Other Intervention Name(s)

REVITALIZE

Intervention Description

Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.

Primary Outcome Measure Information:

Title

Time Frame

4 months from procedure

Secondary Outcome Measure Information:

Title

Freedom from Major Adverse Cardiac Event (MACE)

Time Frame

12 months from procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Maximal cardiac troponin elevation ≥ 4 (measured at 37° C) Age 18 - 80 Years Written informed consent Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raj Makkar, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

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