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
Price :
$35
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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
- 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