Adult Stem Cell Therapy in Liver Insufficiency

NCT ID: NCT00147043

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-06-30

Brief Summary

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

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Stem Cells

Group Type: EXPERIMENTAL

Leukapheresis

Intervention Type: PROCEDURE

Infusion of stem cells via image guided scan

Intervention Type: PROCEDURE

Interventions

Leukapheresis

Intervention Type: PROCEDURE

Infusion of stem cells via image guided scan

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagy Habib, ChM FRCS

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Hammersmith Hospitals NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

Gordon MY, Levicar N, Pai M, Bachellier P, Dimarakis I, Al-Allaf F, M'Hamdi H, Thalji T, Welsh JP, Marley SB, Davies J, Dazzi F, Marelli-Berg F, Tait P, Playford R, Jiao L, Jensen S, Nicholls JP, Ayav A, Nohandani M, Farzaneh F, Gaken J, Dodge R, Alison M, Apperley JF, Lechler R, Habib NA. Characterization and clinical application of human CD34+ stem/progenitor cell populations mobilized into the blood by granulocyte colony-stimulating factor. Stem Cells. 2006 Jul;24(7):1822-30. doi: 10.1634/stemcells.2005-0629. Epub 2006 Mar 23.

Reference Type: RESULT

PMID: 16556705 (View on PubMed)

Other Identifiers

2004/6746

Identifier Type: -

Identifier Source: org_study_id