Status:
COMPLETED
A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
Lead Sponsor:
Imperial College London
Conditions:
Liver Disease
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This is a prospective dose escalation study of the administration of expanded autologous adult human stem cells in patients with chronic liver insufficiency. Four groups of two patients will receive a...
Eligibility Criteria
Inclusion
- Male or female patients aged from 20 to 65 years of age
- Evidence of chronic liver insufficiency
- The presence of abnormal serum albumin and/or bilirubin and/or prothrombin time
- Patient is unlikely to receive a liver transplant
- Has a World Health Organisation (WHO) performance score of less than 2
- Has a life expectancy of at least 3 months
- Ability to give written consent
- Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
Exclusion
- Patients below the age of 20 or above the age of 65 years
- Pregnant or lactating women
- Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
- Patients with evidence of HIV or other life threatening infection
- Patients unable to give written consent
- Patients with a history of hypersensitivity to Granulocyte-Colony Stimulating Factor (F-CSF)
- Patients who have been included in any other clinical trial within the previous month
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00655707
Start Date
January 1 2006
End Date
April 1 2009
Last Update
October 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imperial College Healthcare Trust
London, United Kingdom, W12 0HS