Hepatic Artery Infusion of CD34+ Cells
|Stem Cell Transplantation Liver Diseases||Procedure: Hepatic artery infusion of CD34+ cells Device: Cobe Spectra||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- 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 ]
|Study Start Date:||May 2002|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062543
|Principal Investigator:||Zeev Estrov, MD||M.D. Anderson Cancer Center|