Trials / Completed
CompletedNCT01765283
Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)
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
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Cellaion SA · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD. The study duration: 12 months starting from the day of treatment: 6 months active surveillance and 6 months observation post-infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HepaStem |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2014-10-01
- Completion
- 2015-04-01
- First posted
- 2013-01-10
- Last updated
- 2020-10-19
Locations
11 sites across 5 countries: Belgium, France, Israel, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT01765283. Inclusion in this directory is not an endorsement.