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Cardiac Regenerative Therapy
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC) (DYNAMIC Trial)
Phase 1
Waitlist Available
Led By Rajendra (Raj) Makkar, MD
Research Sponsored by Capricor Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
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.
Eligible Conditions
- Heart Failure
- Non Ischemic Cardiomyopathy
- Cardiomyopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Allogeneic Cardiosphere-Derived CellsExperimental Treatment1 Intervention
The Phase I study consists of a Phase Ia portion and a Phase Ib portion. The Phase Ia portion (N=14 subjects) consists of an open-label, single-arm, study design. The potentially conducted Phase Ib portion of the study (N=28 subjects) consists of a double-blind, randomized, placebo-controlled study design.
The Phase Ia portion is an open-label, dose escalation of Allogeneic Cardiosphere-Derived Cells (CDCs).
Group II: PlaceboPlacebo Group1 Intervention
The placebo study arm only applies to the Phase Ib portion of the study design. The Phase Ia portion (N=14 subjects) consists of an open-label, single-arm, study design. The potentially conducted Phase Ib portion of the study (N=28 subjects) consists of a double-blind, randomized, placebo-controlled study design.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,191 Total Patients Enrolled
35 Trials studying Heart Failure
7,829 Patients Enrolled for Heart Failure
Capricor Inc.Lead Sponsor
11 Previous Clinical Trials
446 Total Patients Enrolled
2 Trials studying Heart Failure
22 Patients Enrolled for Heart Failure
Cedars-Sinai Medical CenterOTHER
513 Previous Clinical Trials
163,347 Total Patients Enrolled
12 Trials studying Heart Failure
10,049 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,790 Total Patients Enrolled
209 Trials studying Heart Failure
677,639 Patients Enrolled for Heart Failure
Rajendra (Raj) Makkar, MDPrincipal InvestigatorCedars-Sinai Medical Center, Heart Institute
Deborah Ascheim, MDStudy DirectorCapricor Inc.
4 Previous Clinical Trials
341 Total Patients Enrolled
2 Trials studying Heart Failure
18 Patients Enrolled for Heart Failure