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A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Promethera HepaStem in Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) Paediatric Patients.

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Trial Profile

A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Promethera HepaStem in Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) Paediatric Patients.

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Mesenchymal stem cell therapy (Primary)
  • Indications Crigler-Najjar syndrome; Inborn urea cycle disorders
  • Focus Adverse reactions; First in man
  • Acronyms HEP 001; UKHEP001
  • Sponsors Cellaion; Promethera Biosciences
  • Most Recent Events

    • 18 Feb 2019 Results evaluating safety and preliminary efficacy of HepaStem in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients published in the Transplantation
    • 18 May 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 17 Feb 2014 New trial record
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