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An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

NCT01670981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-05-27

No results posted yet for this study

Summary

This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

Conditions

  • Ischemic Dilated Cardiomyopathy (IDCM)

Interventions

BIOLOGICAL

ixmyelocel-T

12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.

OTHER

Placebo

12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-20
Primary Completion
2016-02-01
Completion
2018-03-07

Countries

  • United States
  • Canada

Study Locations

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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 NCT01670981 on ClinicalTrials.gov