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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

Phase 1
Not Enrolling
Stem Cell Transplantation, Liver Diseases

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Trial Information

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

Participants in this study have received stem cell transplantation. As a result of this
procedure, participants have developed severe liver dysfunction. Researchers have recently
discovered that cells circulating in the blood and bone marrow are capable of forming liver
cells. Before taking part in this study, women able to have children must have a negative
blood pregnancy test.

Participants in this study will have donor's cells infused directly into their liver through
a catheter that will be inserted through the groin. This will be done after liver disease
has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3
days. During that time, participants will be exposed to repeated x-ray exams to ensure that
the catheter stays in place.

During the time that the catheter is in place, the infusion will be repeated as long as
donor's cells are available. Participants will receive different drugs by vein to decrease
the risk of transfusion reaction. After completing donor cell infusion, the catheter will
be removed.

After participants are released from the hospital, they will have periodic evaluation of
liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate
liver function. Around Days 28 and 90, participants will have liver biopsy.

This is an investigational study. A total of 10 patients will take part in this study. All
will be enrolled at UTMDACC.

Inclusion Criteria:

- 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 Criteria:

- Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 Years

Safety Issue:


Principal Investigator

Zeev Estrov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

October 2005

Related Keywords:

  • Stem Cell Transplantation
  • Liver Diseases
  • Severe hepatic dysfunction post stem cell transplantation
  • Stem Cell Transplantation
  • Hepatic Artery Infusion
  • Liver Diseases
  • CD34+ Cells
  • SCT
  • Liver Diseases