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

Stopped early · Phase 2

Conditions studied: Urea Cycle Disorders

In brief

Treatment with liver cell infusion for children with urea cycle disorders (UCD).

Key facts

Study ID

NCT01195753

Run by

Cytonet GmbH & Co. KG

People needed

10

Starts

2010-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-08

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: birth up to 5 years of age
• Ornithine transcarbamylase deficiency [OTCD], Carbamyl phosphate synthetase I deficiency [CPSD], Argininosuccinate synthetase deficiency [ASSD, Citrullinaemia]
• Written Informed Consent

You may not qualify if…

• Weight ≤ 3.5 kg
• Presence of acute infection at the time of inclusion
• Severe chronic or systemic disease other than study indication
• Structural liver disease (eg, cirrhosis, portal hypertension)
• Required valproate therapy

Where it is running

• Stanford University — Palo Alto, California, United States
• University of California — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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