Liver Disease Clinical Trial
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
Verified date | October 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Who Tolerated the Maximum Dose | To determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein. | 12 months | |
Primary | Number of Participants Without Specific Treatment Related Side Effect | To assess the safety of ascending doses of autologous adult stem cells when introduced into either the hepatic artery or the portal vein and to determine the maximum tolerated dose of stem cells. | 12 months |
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