Hepatic Artery Infusion of CD34+ Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00062543
Recruitment Status : Withdrawn
First Posted : June 12, 2003
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplantation Liver Diseases Procedure: Hepatic artery infusion of CD34+ cells Device: Cobe Spectra Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Arm Intervention/treatment
Experimental: Hepatic Artery Infusion
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+ cells
Donor's cells infused directly into liver through a groin catheter (hepatic artery).
Device: Cobe Spectra
Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).
Other Name: blood cell separator

Primary Outcome Measures :
  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. [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00062543

Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Zeev Estrov, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00062543     History of Changes
Other Study ID Numbers: ID02-167
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases