Hepatic Artery Infusion of CD34+ Cells - Full Text View

Hepatic Artery Infusion of CD34+ Cells

This study has been completed.

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00062543

Purpose

The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.

Condition	Intervention	Phase
Stem Cell Transplantation Liver Diseases	Procedure: Hepatic artery infusion of CD34+ cells	Phase I

MedlinePlus related topics:

Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Hepatic Artery Infusion of CD34+ Cells, Isolated by the Isolex 300i Device, in Stem Cell Transplant Recipients With Hepatic Failure Due to Veno-Occlusive Disease

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	10
Study Start Date:	May 2002
Estimated Study Completion Date:	October 2005

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.
The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.
The patient must have complete donor chimerism.

Exclusion:

Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for infusion.
Patients with graft versus host disease (GVHD).
Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.
Patients with active hepatitis B or C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062543

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Zeev Estrov, MD	U.T.M.D. Anderson Cancer Center

More Information

Study ID Numbers:	ID02-167
First Received:	June 9, 2003
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00062543
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Severe hepatic dysfunction post stem cell transplantation

Stem Cell Transplantation

Hepatic Artery Infusion

Liver Diseases

CD34+ Cells

SCT

Study placed in the following topic categories:

Liver Failure

Liver Diseases

Digestive System Diseases

ClinicalTrials.gov processed this record on November 30, 2008