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. 2021 Jul 21;2021(7):CD013433. doi: 10.1002/14651858.CD013433.pub2

NCT02293603.

Study name Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally‐regenerative Cells (DYNAMIC)
Methods Phase Ia: open‐label, single‐arm, dose escalation of allogeneic cardiosphere‐derived cells  (14 participants)
Phase Ib: double‐blind, randomized, placebo‐controlled study design (28 participants)
Participants Major inclusion criteria: DCM with LVEF ≤ 35% as determined by a historical TTE within the previous 6 months; NYHA class III or ambulatory class IV heart failure; use of evidence based medical‐therapy (beta‐blockers, angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers, aldosterone antagonist) and with or without device‐therapy (implantable cardioverter‐defibrillator or cardiac resynchronizing therapy), in accordance with the American College of Cardiology/American Heart Association guidelines for the management of heart failure, for ≥ 3 months prior to enrolment or documented contraindication or intolerance or participant preference
Note: unclear if the study includes people with ischaemic cardiomyopathy, or a mixed population.
Interventions SCT group: allogeneic cardiosphere‐derived cells
Intracoronary delivery of CAP‐1002
Control: placebo
Outcomes  
Starting date  
Contact information  
Notes Sponsor: Capricor Inc.
Ongoing (not recruiting). Expected date of finalization: 2020.