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Cardiac Regenerative Therapy

Allogeneic Cardiosphere-Derived Cells for Heart Failure (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 within one month of intracoronary infusion
Awards & highlights

DYNAMIC Trial 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
  • Dilated Cardiomyopathy
  • Cardiomyopathy

DYNAMIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the six & twelve month follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the six & twelve month follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
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).
Proportion of subjects that experience new TIMI flow 0-2 or TIMI myocardial perfusion grade (TMPG) 0-2.
+2 more
Secondary outcome measures
Acute myocarditis possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular immune reaction specific to CAP-1002 must also be documented.
Any hospitalization due to a cardiovascular cause or related to CAP-1002 (or placebo in Phase Ib).
Any inter-current cardiovascular illness or one related to CAP-1002 (or placebo in Phase Ib) which prolongs hospitalization.
+7 more

DYNAMIC 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
2,705 Previous Clinical Trials
7,507,179 Total Patients Enrolled
35 Trials studying Heart Failure
7,844 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
500 Previous Clinical Trials
164,821 Total Patients Enrolled
11 Trials studying Heart Failure
10,012 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
2014. "Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02293603.
All > Cardiomyopathy
~4 spots leftby May 2025
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