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The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)

NCT02013674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-11

Study results available
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Summary

Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.

Conditions

Interventions

BIOLOGICAL

Allogeneic hMSCs

Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Joshua M Hare, MD · ISCI / University of Miami Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-13
Primary Completion
2017-03-02
Completion
2017-09-18
FDA Drug
Yes

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 NCT02013674 on ClinicalTrials.gov