Bone Marrow Stem Cell Infusion Following a Heart Attack

• ClinicalTrials.gov Identifier: NCT00268307
• Recruitment Status: Completed
• First Posted: December 22, 2005
• Last Update Posted: December 5, 2013
• Sponsor: Minneapolis Heart Institute Foundation
• Collaborator: Allina Health System
• Information provided by (Responsible Party): Minneapolis Heart Institute Foundation

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.

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction	Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
• Study Start Date: December 2005
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Safety as measured by holter monitor, laboratory assessments, and cardiac MRI [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Sponsors and Collaborators

Minneapolis Heart Institute Foundation

Allina Health System

Investigators

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

More Information

Additional Information:

click here for more information on this study 

Publications of Results:

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.

• Responsible Party: Minneapolis Heart Institute Foundation
• ClinicalTrials.gov Identifier: NCT00268307 History of Changes
• Other Study ID Numbers: opt001
• First Posted: December 22, 2005
• Last Update Posted: December 5, 2013
• Last Verified: December 2013

Keywords provided by Minneapolis Heart Institute Foundation:

Cell therapy

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases