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Hepatic Artery Infusion of CD34+ Cells

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00062543
First received: June 9, 2003
Last updated: August 1, 2012
Last verified: August 2012
History of Changes

June 9, 2003
August 1, 2012
May 2002
October 2005   (final data collection date for primary 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00062543 on ClinicalTrials.gov Archive Site
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Hepatic Artery Infusion of CD34+ Cells
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

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stem Cell Transplantation
  • Liver Diseases
  • 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
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.
Interventions:
  • Procedure: Hepatic artery infusion of CD34+ cells
  • Device: Cobe Spectra
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00062543
ID02-167
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Zeev Estrov, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP