Last updated on November 2017

Stem Cell Trial for Patients with Heart Failure due to Ischemic Dilated Cardiomyopathy


Brief description of study

Stem Cell Trial for Patients with Heart Failure due to Ischemic Dilated Cardiomyopathy

Detailed Study Description

This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females;
  • Age 30 to 85 years of age;
  • Diagnosis of ischemic dilated cardiomyopathy according to WHO criteria:
    Ischemic dilated cardiomyopathy is defined as dilated cardiomyopathy in a subject with a history of myocardial infarction or evidence of clinically significant ( ≥70% narrowing of a major epicardial artery) coronary artery disease;
  • LVEF ≤30% by echocardiogram;
  • Symptomatic heart failure in NYHA functional class III or IV;
  • Subject is not a candidate for reasonable revascularization procedures that will produce clinical improvement, based on coronary angiography (angiography current within 12 months prior to screening);
  • Subject is receiving appropriate clinical standard of care heart failure therapy, as tolerated and as dictated by a subject's current medical condition, for at least 30 days prior to screening;
  • Must have an automatic implantable cardioverter defibrillator (AICD);
  • Worsening heart failure hospitalization or equivalent within 6 months prior to screening, hospitalization equivalent defined as an unplanned outpatient/emergency department visit for treatment with intravenous inotrope, vasoactive, or diuretic medication;
  • Life expectancy of at least 12 months in the opinion of the Investigator;
  • LV wall thickness ≥8mm (by echocardiogram) at anticipated target injection area;
  • Hemodynamic stability without IV vasopressors or support devices;
  • Given medical history and concurrent medication, subject is an acceptable candidate for bone marrow aspiration and cardiac catheterization and transendocardial injection procedures in the opinion of the Investigator;
  • Subject is willing and able to comply with scheduled study visits, and is able to tolerate study procedures;
  • Provide a personally-signed and dated informed consent document indicating that the subject (or a legally-acceptable representative, if permitted by the site's Investigational Review Board [IRB]) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency;
  • VAD implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, or cardiac shunt implantation;
  • Planned heart failure-related device interventions (e.g., VAD implantation, initial cardiac resynchronization therapy) or planned cardiac procedures (e.g., heart transplant, cardiomyoplasty, valvular repair);
  • Subject has any current arrhythmias that would prohibit accurate NOGA® electromechanical mapping and NOGA®-guided injections;
  • LV thrombus (as documented on echocardiography or LV angiography);
  • Myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening;
  • Percutaneous coronary intervention, valvuloplasty, cardiac surgery, and other major cardiac procedure within 30 days prior to screening;
  • In the opinion of the Investigator, the subject's left ventricular wall is unsuitable for transendocardial injections (due to thickness or other reasons).
    Medical History:
  • Known history of severe chronic obstructive pulmonary disease (COPD) (defined as forced expiratory volume (FEV1) <30% predicted);
  • Hemoglobin A1c (HbA1c) = 10% at screening;
  • Diabetic subjects with uncontrolled or untreated proliferative retinopathy as determined by dilated eye exam administered by a qualified eye care professional as per American Diabetes Association guidelines;
  • Blood clotting disorder not caused by medication (e.g., thrombophilia);
  • Active malignancy (non-basal cell) requiring surgery, chemotherapy, and/or radiation in the past 12 months;
  • Current documented drug or alcohol abuse that would interfere with the subject's compliance with study procedures;
  • Known allergies to any equine, porcine, or bovine products;
  • Body mass index (BMI) ≥40 kg/m2 at screening;
  • Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated creatinine clearance < 15 mL/min at screening;
  • Subject has allergy or is unable to tolerate echocardiography contrast agent; also the inability to get a good quality echocardiogram image at screening (as determined by the imaging core lab).
    Laboratory Parameters:
  • Abnormal laboratory values (performed at central lab) at screening:
    • Platelets < 50,000 µL;
    • Hemoglobin < 9.0 g/dL;
    • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal (ULN);
    • Human immunodeficiency virus 1 (HIV 1), HIV 2, or syphilis positive (rapid plasma reagin [RPR]);
    • Active hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
    • NOTE: Additional lab tests may be performed per local requirements including but not limited to: hepatitis B core antibody, human T lymphotropic virus I/II. Exclusionary Procedures, Devices, or Medication:
  • Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth factor [VEGF]);
  • Subjects receiving treatment with hematopoietic growth factors (e.g., erythropoietin [EPO], granulocyte colony-stimulating factor [G-CSF]);
  • Chronic exposure to immunosuppressive therapy for oncologic or chronic non-oncologic reasons in the prior 6 months or expected requirement over the course of the study;
  • Concurrent participation in another clinical trial or receiving experimental medication within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product [previously known as tissue repair cells (TRC), cardiac repair cells (CRC), vascular repair cells (VRC)] or previously received intracoronary or intramyocardial injections of any other bone marrow therapies.

Clinical Study Identifier: TX13525

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Lauraine Crandall

Cardiology Research Associates
Daytona Beach, FL USA
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