Bone Marrow Stem Cell Infusion Following a Heart Attack

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268307
• Other study ID #: opt001
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2005
• Last updated: December 3, 2013
• Start date: December 2005
• Est. completion date: September 2010

Study information

• Verified date: December 2013
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Abbott Northwestern Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by holter monitor, laboratory assessments, and cardiac MRI		6 months	Yes
Secondary	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.		6 months	No

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