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Adult Stem Cell Therapy in Liver Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00147043
First received: September 5, 2005
Last updated: December 13, 2005
Last verified: September 2005
  Purpose

In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs.

Objectives:

  1. To assess safety and treatment related toxicities
  2. To determine clinical benefit or deterioration by monitoring changes in liver function

Condition Intervention Phase
Liver Cirrhosis
Procedure: Leukapheresis
Procedure: Infusion of stem cells via image guided scan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adult Stem Therapy for Patients With Liver Insufficiency

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • To assess safety and treatment related toxicities

Secondary Outcome Measures:
  • To determine clinical benefit or deterioration by monitoring changes in liver function

Estimated Enrollment: 5
Study Start Date: January 2005
Estimated Study Completion Date: June 2005
Detailed Description:

The liver in an adult healthy body maintains a balance between cell gain and cell loss. Though normally proliferatively quiescent, hepatocyte loss such as that caused by partial hepatectomy, uncomplicated by virus infection or inflammation, invokes a rapid regenerative response to restore liver mass. This restoration of moderate cell loss and 'wear and tear' renewal is largely achieved by hepatocyte self-replication. More severe liver injury can activate a potential stem cell compartment located within the intrahepatic biliary tree, giving rise to cords of bipotential, so-called, oval cells within the lobules that can differentiate into hepatocytes and biliary epithelial cells. A third population of stem cells with hepatic potential reside in the bone marrow; these haematopoietic stem cells can contribute to the albeit low renewal rate of hepatocytes, make a more significant contribution to regeneration and even completely restore normal function in a murine model of hereditary tyrosinaemia.

A recent abstract has suggested that an astonishingly high number of bone marrow cells (~25% of liver parenchyma occupied by bone marrow-derived cells) will engraft and differentiate into hepatocytes in a model of cirrhosis in the mouse when injected intravenously. More importantly, this bone marrow infusion resulted in significant improvements in liver function (serum albumin) within the cirrhotic animals.

This is a safety and toxicity study in five patients with chronic liver disease. Each will receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein under image guided scanning. Patients will be followed for a total of 60 days.

  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 aged from 20 years to 65 years Evidence of chronic liver failure Abnormal serum albumin and/or bilirubin and/or prothrombin time Unsuitable for liver transplantation WHO performance status <2 Women of childbearing potential may be included but must use a reliable and appropriate contraceptive method Life expectancy of at least three months Ability to give informed consent

Exclusion Criteria:

- Patients aged below 20 years or above 65 years Pregnant or lactating women Patients with recent recurrent gastrointestinal bleeding Spontaneous bacterial peritonitis Evidence of active infection HIV infection Patients unable to give informed consent

  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: NCT00147043

Locations
United Kingdom
Hammersmith Hospitals NHS 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

ClinicalTrials.gov Identifier: NCT00147043     History of Changes
Other Study ID Numbers: 2004/6746, DSGH PX0447
Study First Received: September 5, 2005
Last Updated: December 13, 2005
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Adult stem cells
Liver disease
CD34 positive cells

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

ClinicalTrials.gov processed this record on November 23, 2014