Open, Prospective, Uncontrolled, Multicentre Study to Evaluate The Safety and Efficacy of Multiple Applications of Liver Cell Suspension Into The Portal Vein in Children With Urea Cycle Disorders (UCDs)

Trial Profile

Open, Prospective, Uncontrolled, Multicentre Study to Evaluate The Safety and Efficacy of Multiple Applications of Liver Cell Suspension Into The Portal Vein in Children With Urea Cycle Disorders (UCDs)

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Apr 2016

At a glance

  • Drugs Liver cell therapy (Primary)
  • Indications Inborn urea cycle disorders
  • Focus Adverse reactions; Registrational
  • Acronyms SELICA V
  • Sponsors Cytonet
  • Most Recent Events

    • 05 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials gov.
    • 26 Jun 2015 The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Heparesc for the treatment of certain urea cycle disorders, according to an EMA media release.
    • 09 Dec 2014 Planned End Date changed from 1 Dec 2014 to 1 Dec 2015 as reported by ClinicalTrials gov.
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