Clinical Trials Logo
  1. Home
  2. Urea Cycle Disorders
  3. NCT01765283

Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) — HEP001  

Urea Cycle Disorders Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01765283
Study type Interventional
Source Promethera Biosciences
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2012
Completion date April 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT02252770 - Nitric Oxide Supplementation in Argininosuccinic Aciduria N/A
Completed NCT01002469 - Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment N/A
Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
Completed NCT01257737 - To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs) Phase 4
Recruiting NCT05671666 - Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients N/A
Completed NCT02311283 - Pilot Study: Urea Cycle Disorders Practice Patterns and Outcomes Assessment N/A
Completed NCT02489292 - Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002) Phase 2
Completed NCT00992459 - Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders Phase 3
Completed NCT00551200 - Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders Phase 2
Completed NCT00947297 - Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD) Phase 3
Completed NCT02740153 - PCORI Urea Cycle Disorder Study
Completed NCT02051049 - Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)
Completed NCT00947544 - Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders Phase 2
Completed NCT01347073 - Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs) Phase 3
Completed NCT00718627 - Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders Phase 2
Completed NCT03797131 - Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders N/A
Completed NCT01549015 - Study in Healthy Subjects, Patients With Urea Cycle Disorders (UCD) and Carriers of UCD Mutations to Evaluate Urea Cycle Function N/A
Terminated NCT01541722 - Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders N/A
Completed NCT00345605 - Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder Phase 2
Recruiting NCT00237315 - Longitudinal Study of Urea Cycle Disorders