Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062543
Status:
WITHDRAWN
Last Update Posted:
2018-10-29
First Post:
2003-06-09
Brief Title:
Hepatic Artery Infusion of CD34 Cells
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 donors 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 donors 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
Participants in this study will have donors 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 donors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None