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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02798861 -
Controlled Attenuation Parameter (CAP) in Liver Allografts
|
||
Completed |
NCT01968395 -
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
|
Phase 4 | |
Completed |
NCT01437969 -
Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
|
||
Recruiting |
NCT00155376 -
Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography
|
Phase 4 | |
Recruiting |
NCT00172705 -
Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique
|
N/A | |
Completed |
NCT04185454 -
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese
|
N/A | |
Completed |
NCT02506335 -
Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease
|
Early Phase 1 | |
Completed |
NCT02520609 -
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
|
||
Completed |
NCT02306018 -
Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation
|
N/A | |
Completed |
NCT01970904 -
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
|
N/A | |
Completed |
NCT01988753 -
Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
|
||
Terminated |
NCT00741117 -
Conjugated Hyperbilirubinemia and Pulse Oximetry
|
N/A | |
Enrolling by invitation |
NCT01483248 -
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
|
Phase 1/Phase 2 | |
Completed |
NCT00074386 -
Kidney and Liver Transplantation in People With HIV
|
N/A | |
Completed |
NCT00245830 -
Ischemic Preconditioning of Liver in Cadaver Donors
|
N/A | |
Completed |
NCT02329821 -
Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection
|
N/A | |
Completed |
NCT01650181 -
Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
|
Phase 4 | |
Completed |
NCT01303549 -
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
|
Phase 4 | |
Completed |
NCT00799851 -
A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
|
Phase 4 | |
Completed |
NCT00058890 -
Gabapentin to Treat Itch in Patients With Liver Disease
|
Phase 3 |