Try our beta test site

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) (ixCELL DCM)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vericel Corporation Identifier:
First received: August 20, 2012
Last updated: March 22, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Ischemic Dilated Cardiomyopathy (IDCM)
Biological: ixmyelocel-T
Other: Vehicle Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Vericel Corporation:

Primary Outcome Measures:
  • Average number of clinical events over 12 months post-treatment. [ Time Frame: 12 Months ]
    The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.

Secondary Outcome Measures:
  • The win ratio of the hierarchical occurrence of all-cause deaths/left ventricular assist device (LVAD) implant/heart transplant, cardiovascular hospitalizations, and unplanned outpatient and ED interventions to treat ADHF [ Time Frame: 12 Months ]
    This is a composite end point. This endpoint will be primarily assessed excluding events considered to be related to administration of IP. An analysis including IP administration-related events will also be conducted as part of the sensitivity analyses.

  • Change from baseline to 12 months post-treatment in 6-minute walk test. [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the changes from baseline to 12 months post-treatment in the distance walked as measured by the 6-minute walk test.

  • Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography. [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the change in left ventricular function as measured by echocardiography for left ventricular ejection fraction (LVEF).

  • Change from baseline to 12 months post-treatment in quality of life. [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the change in quality of life (total score) in patients treated with ixmyelocel-T compared to placebo using the Minnesota Living with Heart Failure Questionnaire.

  • Change from baseline to 12 months post-treatment in NYHA Classification. [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the change from baseline to Month 12 in NYHA Classification in patients treated with ixmyelocel-T compared to placebo.

  • Percent of patients with adverse events. [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM from time of aspiration through 12 months post-treatment/follow-up by % of patients with adverse events.

  • Percent of patients with major adverse cardiac events (MACE). [ Time Frame: 12 Months ]
    A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM by the percentage of patients who experience MACE events. MACE events include: unstable angina requiring hospitalization, myocardial infarction, stroke, worsening heart failure requiring hospitalization, VAD implantation, heart transplant, resuscitated sudden death, and cardiovascular death.

Enrollment: 114
Study Start Date: October 2012
Estimated Study Completion Date: February 2017
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ixmyelocel-T
Ixmyelocel-T delivered by catheter-based intramyocardial injection procedure.
Biological: ixmyelocel-T
12-20 transendocardial NOGA® -guided injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.
Placebo Comparator: Vehicle Control
Placebo delivered by catheter-based intramyocardial injection procedure.
Other: Vehicle Control
12-20 transendocardial NOGA® -guided injections of 0.4 mL of vehicle control per injection into the left ventricle.

Detailed Description:
The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

Ages Eligible for Study:   30 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01670981

  Hide Study Locations
United States, Alabama
Cardiology, P.C. & Center for Therapeutic Angiogenesis
Birmingham, Alabama, United States, 35211
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
UCSD Medical Center
La Jolla, California, United States, 92037
Cedars-Sinai Heart and Lung Institute
Los Angeles, California, United States, 90048
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
St. John's Regional Medical Center
Oxnard, California, United States, 93030
Stanford University
Stanford, California, United States, 94305
United States, Florida
Cardiology Research Associates
Daytona Beach, Florida, United States, 32117
University of Florida - Division of Cardiology
Gainesville, Florida, United States, 32610
Mayo Clinic Florida (Jacksonville)
Jacksonville, Florida, United States, 32224
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital, Division of Cardiology
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan CardioVascular Institute
Saginaw, Michigan, United States, 48602
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Newark Beth Israel Hospital
Newark, New Jersey, United States, 07112
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
The Carl and Edyth Linder Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
University Hospitals - Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Veterans Administration Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States, 38138
United States, Texas
Soltero Cardiovascular Research Center
Dallas, Texas, United States, 75226
Methodist DeBakey Heart and Vascular Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Services Center
Salt Lake City, Utah, United States, 84132
United States, Washington
Swedish Medical Center - Cherry Hill Professional Building
Seattle, Washington, United States, 98122
United States, Wisconsin
University of Wisconsin-Madison Cardiovascular Medicine
Madison, Wisconsin, United States, 53792
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 287
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Vericel Corporation
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vericel Corporation Identifier: NCT01670981     History of Changes
Other Study ID Numbers: ABI 55-1202-1 
Study First Received: August 20, 2012
Last Updated: March 22, 2016

Keywords provided by Vericel Corporation:
Ischemic dilated cardiomyopathy
Heart failure
stem cells
cell therapy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiomegaly processed this record on February 24, 2017