Trial Search Results

An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Vericel Corporation

Stanford Investigator(s):

Intervention(s):

  • Biological: ixmyelocel-T
  • Other: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Males and non-pregnant, non-lactating females;

   2. Age 30 to 86 years of age;

   3. Diagnosis of ischemic dilated cardiomyopathy;

   4. LVEF ≤ 35% by echocardiogram;

   5. Symptomatic heart failure in NYHA functional class III or IV;

   6. Subject is not a candidate for reasonable revascularization procedures that will
   produce clinical improvement;

   7. 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;

   8. Must have an automatic implantable cardioverter defibrillator (AICD);

   9. 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; or 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); or have a 6-minute walk test
   (6MWT) distance of ≤400 meters at screening;

10. Life expectancy of at least 12 months in the opinion of the Investigator;

11. LV wall thickness ≥ 7mm (by echocardiogram) at anticipated target injection area;

12. Hemodynamic stability without IV vasopressors or support devices;

13. 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;

14. Willing and able to comply scheduled visits and tolerate study procedures.

15. Voluntarily provide a personally-signed and dated informed consent.

Exclusion Criteria:

Disease-specific:

   1. Severe primary valvular heart disease including, but not limited to, aortic valve
   stenosis and insufficiency;

   2. VAD implantation, heart transplantation, cardiomyoplasty, left ventricular reduction
   surgery, or cardiac shunt implantation;

   3. 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);

   4. Current arrhythmias that would prohibit accurate NOGA® electromechanical mapping and
   NOGA®-guided injections;

   5. LV thrombus (as documented on echocardiography or LV angiography);

   6. Myocardial infarction, stroke or transient ischemic attack within 3 months prior to
   screening;

   7. Percutaneous coronary intervention, valvuloplasty, cardiac surgery, and other major
   cardiac procedure within 30 days prior to screening;

   8. 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:

   9. Stroke or transient ischemic attack (TIA) within 3 months of screening;

10. Hemoglobin A1c (HbA1c) ≥ 9% at screening;

11. 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;

12. Blood clotting disorder not caused by medication (e.g., thrombophilia);

13. Active malignancy (non-basal cell) requiring surgery, chemotherapy, and/or radiation
   in the past 12 months;

14. Drug or alcohol abuse that would interfere with the subject's compliance with study
   procedures;

15. Allergies to any equine, porcine, or bovine products;

16. Body mass index (BMI) ≥ 40 kg/m2 at screening;

17. Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated
   creatinine clearance < 15 mL/min at screening;

18. Subject has allergy or is unable to tolerate cardiac imaging contrast agents; also the
   inability to get a good quality echocardiogram image at screening (as determined by
   the imaging core lab).

   Laboratory Parameters:

19. 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:

20. Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth
   factor [VEGF]);

21. 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;

22. 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.

23. 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, or 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 or compromise the subject's safety.

Ages Eligible for Study

30 Years - 86 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Karim Sallam
650-736-2701
Recruiting