A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency

This study has suspended participant recruitment.
(Awaiting IMP license for new GMP suite.)
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00655707
First received: April 4, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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 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.


Condition Intervention Phase
Liver Disease
Biological: Autologous Expanded CD34+ Haemopoietic cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: January 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 G-CSF
  • Patients who have been included in any other clinical trial within the previous month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655707

Locations
United Kingdom
Imperial College Healthcare Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Nagy Habib, ChM FRCS Imperial College London
  More Information

No publications provided

Responsible Party: Professor Nagy Habib, Imperial College London
ClinicalTrials.gov Identifier: NCT00655707     History of Changes
Other Study ID Numbers: HHSC/001
Study First Received: April 4, 2008
Last Updated: April 4, 2008
Health Authority: United Kingdom: Department of Health

Keywords provided by Imperial College London:
Adult stem cell therapy

Additional relevant MeSH terms:
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014