Phase 2
N=5
A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT00655707 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Patients Who Tolerated the Maximum Dose — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Expanded CD34+ Haemopoietic cells (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Tolerated the Maximum Dose |
5 | — |
| PRIMARY Number of Participants Without Specific Treatment Related Side Effect |
5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00655707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.