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. |