NCT01670981

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)

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Vericel Corporation · Industry
• Sex: All
• Age: 30 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Ischemic Dilated Cardiomyopathy (IDCM)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-02-20
• Primary completion: 2016-02-01
• Completion: 2018-03-07
• First posted: 2012-08-23
• Last updated: 2021-05-27

Locations

36 sites across 2 countries: United States, Canada