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Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)

NCT02293603 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-06-21

No results posted yet for this study

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.

Conditions

  • Dilated Cardiomyopathy (DCM)
  • Ischemic Cardiomyopathy
  • Nonischemic Cardiomyopathy
  • Heart Failure

Interventions

BIOLOGICAL

Allogeneic Cardiosphere-Derived Cells (CDCs)

Intracoronary delivery of CAP-1002 or placebo

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Capricor Inc.

    lead INDUSTRY

Principal Investigators

  • Rajendra (Raj) Makkar, MD · Cedars-Sinai Medical Center, Heart Institute

  • Deborah Ascheim, MD · Capricor Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-05-31
Completion
2020-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293603 on ClinicalTrials.gov