Ensayos clínicos

Inclusion Criteria

• Males and non-pregnant, non-lactating females
• Age 30 to 86 years of age
• Diagnosis of ischemic dilated cardiomyopathy
• LVEF ≤ 35% 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
• 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 of acute decompensated heart failure
• Have an N-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥2000 pg/mL or BNP ≥400 pg/mL within 30 days of screening (including screening)
• Have a 6-minute walk test (6MWT) distance of ≤400 meters at screening
• Life expectancy of at least 12 months in the opinion of the Investigator
• LV wall thickness ≥ 7mm (by echocardiogram) at anticipated target injection area
• Hemodynamic stability without IV vasopressors or support devices
• Subject is an acceptable candidate for bone marrow aspiration and cardiac catheterization and transendocardial injection procedures in the opinion of the investigator given the medical history and concurrent medication
• Willing and able to comply with scheduled visits and tolerate study procedures
• Voluntarily provide a personally-signed and dated informed consent.

Exclusion Criteria

• Severe primary valvular heart disease not limited to
  • aortic valve stenosis and insufficiency
  • VAD implantation
  • Heart transplantation
  • Cardiomyoplasty
  • Left ventricular reduction surgery
  • Cardiac shunt implantation
• Planned heart failure-related device interventions e.g.,
  • VAD implantation
  •  Initial cardiac resynchronization therapy
• Planned cardiac procedures e.g.,
  • Heart transplant
  • Cardiomyoplasty
  •  Valvular repair
• 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)
• Stroke or transient ischemic attack (TIA) within 3 months of screening
• Hemoglobin A1c (HbA1c) ≥ 9% 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
• Drug or alcohol abuse that would interfere with the subject's compliance with study procedures
• 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 cardiac imaging contrast agents
• Inability to get a good quality echocardiogram image at screening (as determined by the imaging core lab
• 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
• Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth factor [VEGF])
• Chronic exposure to cytotoxic therapy for oncologic or chronic non-oncologic reasons in the prior 3 months or expected requirement over the course of the study
• Concurrent participation in another interventional clinical trial or receiving experimental intervention within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product or previously received allogeneic cell therapy, autologous cell therapy cultured with animal proteins
• In the opinion of the Investigator, the subject is unsuitable for cellular therapy or has a
  • Food/drug allergy
  • Surgical or medical condition
  • Clinically significant psychiatric disorders
  • Poor nutritional status
  • Lab abnormality requiring further medical evaluation that may
    • Interfere with the investigational product
    • Interfere with the study results' interpretation
    • Interfere with the subject's ability to complete the study 
    • Compromise the subject's safety.