Bone Marrow Stem Cell Infusion Following a Heart Attack

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Minneapolis Heart Institute Foundation.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Abbott Northwestern Hospital

Information provided by:

Minneapolis Heart Institute Foundation

ClinicalTrials.gov Identifier:

NCT00268307

First received: December 20, 2005

Last updated: September 10, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2005

Last Updated Date

September 10, 2010

Start Date ^ICMJE

December 2005

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety as measured by holter monitor, laboratory assessments, and cardiac MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety as measured by holter monitor, laboratory assessments, and cardiac MRI

Change History

Complete list of historical versions of study NCT00268307 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 at 3 months.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bone Marrow Stem Cell Infusion Following a Heart Attack

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Cell therapy

Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.

Intervention: Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells

Publications *

Traverse JH, McKenna DH, Harvey K, Jorgenso BC, Olson RE, Bostrom N, Kadidlo D, Lesser JR, Jagadeesan V, Garberich R, Henry TD. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. Am Heart J. 2010 Sep;160(3):428-34.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2012

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00268307

Other Study ID Numbers ^ICMJE

opt001

Has Data Monitoring Committee

Responsible Party

Jay Traverse, MD, Minneapolis Heart Institute

Study Sponsor ^ICMJE

Minneapolis Heart Institute Foundation

Collaborators ^ICMJE

Abbott Northwestern Hospital

Investigators ^ICMJE

Principal Investigator:

Jay Traverse, MD

Minneapolis Heart Institute

Information Provided By

Minneapolis Heart Institute Foundation

Verification Date

September 2010

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

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