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Clinical Trial 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.


Clinical Trial Description

The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01670981
Study type Interventional
Source Vericel Corporation
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Status Completed
Phase Phase 2
Start date February 20, 2013
Completion date March 7, 2018