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Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders

NCT00718627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-02-08

No results posted yet for this study

Summary

Urea cycle disorders are rare inherited diseases that generally have a poor outcome. In this study, neonates and infants with UCD will be included within the first 3 months of life and will be treated by repetitive application of human liver cells to reduce the risk of neurological deterioration while awaiting OLT.

Conditions

  • Urea Cycle Disorders
  • Carbamoylphosphate Synthetase I Deficiency
  • Ornithine Transcarbamylase Deficiency
  • Citrullinemia

Interventions

BIOLOGICAL

Human Heterologous Liver Cells

Multiple applications of liver cell suspension for infusion

Sponsors & Collaborators

  • Cytonet GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Georg Hoffmann, Prof. · University Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718627 on ClinicalTrials.gov