A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Trial Profile

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Nov 2016

At a glance

  • Drugs Remestemcel-L (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Mesoblast
  • Most Recent Events

    • 25 Jun 2014 Status changed from recruiting to active, no longer recruiting, as per ClinicalTrials.gov record.
    • 25 Jun 2014 Status changed from recruiting to active, no longer recruiting, as per ClinicalTrials.gov record.
    • 20 May 2014 Planned number of patients changed from 270 to 330, as per ClinicalTrials.gov record.
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