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).

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jul 2018

At a glance

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

    • 19 Jul 2018 Status changed from active, no longer recruiting to completed.
    • 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.
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