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)
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
- 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.