Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
United States42 participantsStarted 2014-11
Plain-language summary
To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary infusion in subjects with DCM. The study will further explore safety and exploratory efficacy endpoints of CAP-1002.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. DCM with left ventricular ejection fraction (LVEF) ≤ 35% as determined by a historical TTE within the previous 6 months
✓. New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure
✓. Use of evidence based medical-therapy (beta-blockers, ACE-inhibitors/angiotensin receptor blockers, aldosterone antagonist) and with or without device-therapy (Implantable cardioverter-defibrillator or cardiac resynchronizing therapy), in accordance with the ACC/AHA guidelines for the management of heart failure, for at least three months prior to enrollment or documented contraindication or intolerance or patient preference
✓. Coronary anatomy suitable for Investigational Product (IP) infusion, as determined by the Eligibility Committee (a team of cardiology experts)
✓. Ability to provide informed consent and follow-up with protocol procedures
✓. Screening cardiac CT left ventriculogram ejection fraction \<40% with left ventricular dilatation
✓. Age ≥ 18 years
Exclusion criteria
✕. Diagnosis of active myocarditis
✕. Immunologic incompatibility with all available Master Cell Banks (MCBs) by single-antigen bead (SAB) serum antibody profiling
✕. Left Ventricular Assist Devices (LVAD) or those actively in the process of acquiring one
✕. Recent placement of a cardiac pacemaker and/or resynchronization pacing therapy within the past three months or those actively in the process of acquiring one
What they're measuring
1
Proportion of subjects that experience new TIMI flow 0-2 or TIMI myocardial perfusion grade (TMPG) 0-2.
Timeframe: Intraprocedural
2
Proportion of subjects that experience acute myocarditis, possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular or immune reaction specific to CAP-1002 must also be documented.
Timeframe: Within one month of intracoronary infusion
3
Proportion of subjects that experience ventricular tachycardia or ventricular fibrillation resulting in death, appropriate discharge of an ICD or requiring medical intervention.
Timeframe: During or within 72 hours of intracoronary infusion
4
Proportion of subjects that experience sudden unexpected death occurring within one hour of symptom onset, or un-witnessed death in a person previously observed to be well within the preceding 24 hours without an identified cause.
Timeframe: During or within 72 hours of intracoronary infusion
5
Proportion of subjects that experience major adverse cardiac events (MACE), including death, non-fatal myocardial infarction and re-hospitalization for cardiovascular event (including heart failure hospitalizations).
Timeframe: During or within 72 hours of intracoronary infusion
✕. History of sustained ventricular tachycardia (VT) requiring cardiopulmonary resuscitation (with the exception of subjects who subsequently received an ICD)
✕. Non-cardiovascular disease with life expectancy of \< 3 years