A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
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 cells. Following expansion in an approved 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 .
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.
|Liver Disease||Biological: Autologous Expanded CD34+ Haemopoietic cells||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I/II Safety and Tolerability Dose Escalation Study Following the Autologous Infusion of Expanded Adult Haematopoietic Stem Cells to Patients With Liver Insufficiency|
- To determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein. [ Time Frame: 12 months ]
|Study Start Date:||January 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Autologous CD34+ cells
Biological: Autologous Expanded CD34+ Haemopoietic cells
Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
Patient numbers 01 and 02 will receive 1x109 cells Patient numbers 03 and 04 will receive 1x1010 cells Patient numbers 05 and 06 will receive 2x1010 cells Patient numbers 07 and 08 will receive 5x1010 cells
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655707
|Imperial College Healthcare Trust|
|London, United Kingdom, W12 0HS|
|Principal Investigator:||Nagy Habib, ChM FRCS||Imperial College London|