NCT00874354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

7.9 years

First QC Date

December 26, 2007

Last Update Submit

February 1, 2017

Conditions

Myocardial Infarction

Keywords

Myocardial InfarctionHeart AttackInfarctStem CellsBone Marrow Derived Mononuclear CellsCHFCongestive Heart FailureStentPCIPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months from procedure

Secondary Outcomes (1)

  • Freedom from Major Adverse Cardiac Event (MACE)

    12 months from procedure

Study Arms (1)

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.

Drug: Intracoronary Transplantation of Bone Marrow Stem Cells

Interventions

Intracoronary Transplantation of Bone Marrow Stem CellsDRUG

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

Also known as: REVITALIZE
Autologous bone marrow stem cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionInfarctionHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Raj Makkar, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Interventional Cardiology and Cardiac Catheterization Laboratory

Study Record Dates

First Submitted

December 26, 2007

First Posted

April 2, 2009

Study Start

July 1, 2005

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 2, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)