NCT00062543

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2002

Typical duration for phase_1

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

June 9, 2003

Last Update Submit

October 25, 2018

Conditions

Stem Cell TransplantationLiver Diseases

Keywords

Severe hepatic dysfunction post stem cell transplantationStem Cell TransplantationHepatic Artery InfusionLiver DiseasesCD34+ CellsSCT

Outcome Measures

Primary Outcomes (1)

  • Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.

    3 Years

Study Arms (1)

Hepatic Artery Infusion

EXPERIMENTAL

Donor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes. Cells given as a dose escalation study. First cohort of 3 patients receive 1 \* 106 CD34+ cells/kg. Next 3 patients receive 2.5 \* 106 CD34+cells/kg. Next 3 patients receive 5 \* 106 CD34+ cells/kg. Less than 1 \* 105 T cells/kg administered.

Procedure: Hepatic artery infusion of CD34+ cellsDevice: Cobe Spectra

Interventions

Hepatic artery infusion of CD34+ cellsPROCEDURE

Donor's cells infused directly into liver through a groin catheter (hepatic artery).

Hepatic Artery Infusion
Cobe SpectraDEVICE

Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).

Also known as: blood cell separator
Hepatic Artery Infusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Zeev Estrov, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2003

First Posted

June 12, 2003

Study Start

May 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

October 29, 2018

Record last verified: 2018-10