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)
ixCELLDCM
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM).
1 other identifier
interventional
114
2 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2013
Longer than P75 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedStudy Start
First participant enrolled
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2018
CompletedMay 27, 2021
May 1, 2021
2.9 years
August 20, 2012
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average number of clinical events over 12 months post-treatment.
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.
12 Months
Secondary Outcomes (7)
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
12 Months
Change from baseline to 12 months post-treatment in 6-minute walk test.
12 Months
Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography.
12 Months
Change from baseline to 12 months post-treatment in quality of life.
12 Months
Change from baseline to 12 months post-treatment in NYHA Classification.
12 Months
- +2 more secondary outcomes
Study Arms (2)
ixmyelocel-T
EXPERIMENTALIxmyelocel-T delivered by catheter-based intramyocardial injection procedure.
Placebo
PLACEBO COMPARATORPlacebo delivered by catheter-based intramyocardial injection procedure.
Interventions
12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.
12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.
Eligibility Criteria
You may qualify if:
- 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; 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;
- 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;
- 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;
- Willing and able to comply scheduled visits and tolerate study procedures.
- Voluntarily provide a personally-signed and dated informed consent.
You may not qualify if:
- Disease-specific:
- 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);
- 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:
- 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;
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Cardiology, P.C. & Center for Therapeutic Angiogenesis
Birmingham, Alabama, 35211, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Scripps Clinic
La Jolla, California, 92037, United States
UCSD Medical Center
La Jolla, California, 92037, United States
Cedars-Sinai Heart and Lung Institute
Los Angeles, California, 90048, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
St. John's Regional Medical Center
Oxnard, California, 93030, United States
Stanford University
Stanford, California, 94305, United States
Cardiology Research Associates
Daytona Beach, Florida, 32117, United States
University of Florida - Division of Cardiology
Gainesville, Florida, 32610, United States
Mayo Clinic Florida (Jacksonville)
Jacksonville, Florida, 32224, United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital, Division of Cardiology
Boston, Massachusetts, 02114, United States
Michigan CardioVascular Institute
Saginaw, Michigan, 48602, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Newark Beth Israel Hospital
Newark, New Jersey, 07112, United States
Columbia University Medical Center
New York, New York, 10032, United States
The Carl and Edyth Linder Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals - Case Medical Center
Cleveland, Ohio, 44106, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213, United States
Veterans Administration Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, 38138, United States
Soltero Cardiovascular Research Center
Dallas, Texas, 75226, United States
Methodist DeBakey Heart and Vascular Center
Houston, Texas, 77030, United States
University of Utah Health Services Center
Salt Lake City, Utah, 84132, United States
Swedish Medical Center - Cherry Hill Professional Building
Seattle, Washington, 98122, United States
University of Wisconsin-Madison Cardiovascular Medicine
Madison, Wisconsin, 53792, United States
University of Alberta Hospital
Edmonton, Alberta, T6G 287, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Related Publications (1)
Patel AN, Henry TD, Quyyumi AA, Schaer GL, Anderson RD, Toma C, East C, Remmers AE, Goodrich J, Desai AS, Recker D, DeMaria A; ixCELL-DCM Investigators. Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet. 2016 Jun 11;387(10036):2412-21. doi: 10.1016/S0140-6736(16)30137-4. Epub 2016 Apr 5.
PMID: 27059887DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2012
First Posted
August 23, 2012
Study Start
February 20, 2013
Primary Completion
February 1, 2016
Study Completion
March 7, 2018
Last Updated
May 27, 2021
Record last verified: 2021-05