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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Dilated Cardiomyopathy (IDCM)

In brief

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.

Key facts

Study ID

NCT01670981

Run by

Vericel Corporation

People needed

114

Starts

2013-02-20

Expected to finish

2018-03-07

Last updated by the study team

2021-05-27

Who can join

Age: 30 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

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;
• 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; 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);

Where it is running

• Cardiology, P.C. & Center for Therapeutic Angiogenesis — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Scripps Clinic — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Cedars-Sinai Heart and Lung Institute — Los Angeles, California, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• St. John's Regional Medical Center — Oxnard, California, United States
• Stanford University — Stanford, California, United States
• Cardiology Research Associates — Daytona Beach, Florida, United States
• University of Florida - Division of Cardiology — Gainesville, Florida, United States
• Mayo Clinic Florida (Jacksonville) — Jacksonville, Florida, United States
• University of Miami - Miller School of Medicine — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital, Division of Cardiology — Boston, Massachusetts, United States
• Michigan CardioVascular Institute — Saginaw, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Newark Beth Israel Hospital — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• The Carl and Edyth Linder Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• University Hospitals - Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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