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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raj Makkar, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00874354
First received: December 26, 2007
Last updated: February 1, 2017
Last verified: February 2017
December 26, 2007
February 1, 2017
July 2005
June 2013   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00874354 on ClinicalTrials.gov Archive Site
Freedom from Major Adverse Cardiac Event (MACE) [ Time Frame: 12 months from procedure ]
Same as current
Not Provided
Not Provided
 
Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Myocardial Infarction
Drug: Intracoronary Transplantation of Bone Marrow Stem Cells
Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.
Other Name: REVITALIZE
Experimental: Autologous bone marrow stem cells
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.
Intervention: Drug: Intracoronary Transplantation of Bone Marrow Stem Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00874354
4441
Yes
Not Provided
Plan to Share IPD: No
Raj Makkar, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP