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Bone Marrow Stem Cell Infusion Following a Heart Attack

NCT ID: NCT00268307

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Keywords

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Cell therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cell therapy

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

Group Type EXPERIMENTAL

Autologous, Unfractionated Bone Marrow Mononuclear Cells

Intervention Type DRUG

Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allina Health System

OTHER

Sponsor Role collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Traverse, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute

Locations

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Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.ahj.2010.06.009.

Reference Type RESULT
PMID: 20826249 (View on PubMed)

Related Links

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http://www.mplsheart.org

click here for more information on this study

Other Identifiers

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opt001

Identifier Type: -

Identifier Source: org_study_id