NCT00147043

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
14.1 years until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

September 5, 2005

Results QC Date

February 25, 2019

Last Update Submit

October 2, 2019

Conditions

Liver Cirrhosis

Keywords

Adult stem cellsLiver diseaseCD34 positive cells

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Serious Adverse Events Related to Injection

    Incidence of serious adverse event related to injection with the study participants

    Day 1 to Day 60

Secondary Outcomes (1)

  • Improvement in Liver Function

    Day 1 to Day 60

Study Arms (1)

Autologous Stem Cells

EXPERIMENTAL
Procedure: LeukapheresisProcedure: Infusion of stem cells via image guided scan

Interventions

LeukapheresisPROCEDURE
Autologous Stem Cells
Infusion of stem cells via image guided scanPROCEDURE
Autologous Stem Cells

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospitals NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 16556705RESULT

MeSH Terms

Conditions

Liver CirrhosisLiver Diseases

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Digestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative Techniques

Limitations and Caveats

The study was limited to 5 participants, which is an insufficient number to determine true benefit. A larger Phase I/II should be undertaken to determine benefit.

Results Point of Contact

Title
Professor Nagy Habib
Organization
Imperial College London
nagy.habib@imperial.ac.uk
+442033138574

Study Officials

  • Nagy Habib, ChM FRCS

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Autologous stem cells
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

October 3, 2019

Results First Posted

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)