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Completed

NCT Number: NCT00268307

Bone Marrow Stem Cell Infusion Following a Heart Attack

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous, Unfractionated Bone Marrow Mononuclear Cells

Drug

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

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • Allina Health System

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2005
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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