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Bone Marrow Stem Cell Infusion Following a Heart Attack

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous, Unfractionated Bone Marrow Mononuclear Cells
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Cell therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis Heart Institute Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cell therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 20, 2005
Last Updated
December 3, 2013
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00268307
Brief Title
Bone Marrow Stem Cell Infusion Following a Heart Attack
Official Title
Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Allina Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cell therapy
Arm Type
Experimental
Arm Description
Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.
Intervention Type
Drug
Intervention Name(s)
Autologous, Unfractionated Bone Marrow Mononuclear Cells
Intervention Description
Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.
Primary Outcome Measure Information:
Title
Safety as measured by holter monitor, laboratory assessments, and cardiac MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Traverse, MD
Organizational Affiliation
Minneapolis Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20826249
Citation
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.
Results Reference
result
Links:
URL
http://www.mplsheart.org
Description
click here for more information on this study

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Bone Marrow Stem Cell Infusion Following a Heart Attack

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