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).

Trial Profile

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).

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 10 May 2017

At a glance

  • Drugs Ixmyelocel-T (Primary)
  • Indications Dilated cardiomyopathy; Heart failure
  • Focus Therapeutic Use
  • Acronyms ixCELL-DCM
  • Sponsors Vericel Corporation
  • Most Recent Events

    • 10 May 2017 According to a Vericel Corporation media release, based on the data from this trial the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.
    • 06 Mar 2017 Planned End Date changed from 1 Feb 2017 to 1 Nov 2018.
    • 21 Feb 2017 According to Vericel Corporation media release, based on results of ixCELL-DCM trial the FDA has granted Fast Track Designation to ixmyelocel-T for reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy.
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