Bone Marrow Stem Cell Infusion Following a Heart Attack

December 3, 2013 updated by: Minneapolis Heart Institute Foundation

Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction

The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age at least 21 years of age
  • Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
  • Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
  • Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
  • Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

  • History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
  • Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel.
  • History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
  • History of anemia (Hb < 9.0 mg/dl).
  • History of thrombocytosis.
  • PT or PTT greater than the upper limits of normal.
  • Life expectancy less than one year.
  • Patients on chronic dialysis.
  • History of untreated alcohol or drug abuse.
  • Currently enrolled in another Investigational drug or device trial.
  • History of stroke or TIA within the past 6 months.
  • History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation.
  • Pregnancy
  • Subjects who are HIV, hepatitis B or C positive.
  • Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
  • Contraindications to cardiac MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cell therapy
Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.
Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells
Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as measured by holter monitor, laboratory assessments, and cardiac MRI
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of left ventricular function as assessed by serial measurements of infarct size and LV function by cardiac MRI in the active treatment group versus placebo.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Allina Health System

Investigators

  • Principal Investigator: Jay Traverse, MD, Minneapolis Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • opt001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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