Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC) ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
251Urea cycle disorder1

251. Urea cycle disorder


Clinical trials : 54 Drugs : 61 - (DrugBank : 15) / Drug target genes : 3 - Drug target pathways : 28
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1EUCTR2011-004074-28-IT
(EUCTR)
19/12/201214/01/2013A phase I/II trial for evaluating both safety and preliminary efficacy of one cycle of Promethera Hepastem in Urea Cycle Disorders and Crigler-Najjar Syndrome patientsA prospective, open label, multicenter, partially randomized, safety study of one cycle of Promethera HepaStem in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients - HEP 001 Crigle-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucoronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are six desorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia, argininosuccinic aciduria and argininemia.
MedDRA version: 15.1;Level: LLT;Classification code 10013373;Term: Disorders of urea cycle metabolism;System Organ Class: 100000004861
MedDRA version: 15.1;Level: PT;Classification code 10011386;Term: Crigler-Najjar syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 15.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Promethera HepaStem
Product Code: HHALPC
INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC)
PROMETHERA BIOSCIENCESNULLNot RecruitingFemale: yes
Male: yes
18Phase 1/2Belgium;United Kingdom;Italy