drugset
drugset / Trial / NCT00655707

A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency

NCT00655707 ↗

Phase 1/2 Completed 5 enrolled Imperial College London
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective dose escalation study of the administration of adult human stem cells in patients with end stage liver failure. Successive groups of two patients will receive ascending doses of autologous adult human stem cells starting at 1x10\[9\] cells. Following expansion in an approved Good Manufacturing Practice (GMP) facility the cells will be infused into either the hepatic artery or portal vein of research participants. The aim of this trial is to determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein. The maximum dose that would be given would be 5x10 to the ten \[10\]. To assess improvement in liver function as measured by serological and biochemical analysis and determine whether there are any symptomatic improvements as reported by the patients.

Timeline

Start
2006-01
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 1e+08 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 5e+08 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 1e+09 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 5e+09 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 1e+10 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 2e+10 cells Other
Subject Autologous Expanded CD34+ Haemopoietic cells Cell therapy 5e+10 cells Other

Indications

liver disorder