Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501228
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2007-07-12
Brief Title:
Tissue Repair in Stem Cell Transplant Recipients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
RhG-CSF Filgrastim Treatment of Severe EpithelialEndothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2012-07
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:
Primary Objective
1 To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelialendothelial or solid organ-specific tissue caused by graft-versus-host disease GVHD in patients who underwent sex-mismatched stem cell transplantation
Secondary Objective
1 To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelialendothelial or solid organ-specific tissue
1 To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelialendothelial or solid organ-specific tissue caused by graft-versus-host disease GVHD in patients who underwent sex-mismatched stem cell transplantation
Secondary Objective
1 To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelialendothelial or solid organ-specific tissue
Detailed Description:
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity skin cells andor cells of various organs RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available
Before treatment starts participants will have at least one and up to three biopsyies of damaged tissue performed to find out about the severity of tissue damage A biopsy is taken with a large needle Women able to have children must have a negative blood pregnancy test
Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week This will be repeated every other week for a total of 4 weeks Blood tests about 2 teaspoons each will be performed 3 times while at M D Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range Participants will have at least one and up to three biopsyies again performed about 8 weeks after the start of rhG-CSF treatment An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it and not for research purposes only
Participants will be taken off study if severe side effects occur The study will end after the last biopsy or biopsies are taken about 3 months after the start of rhG-CSF treatment
This is an investigational study RhG-CSF is FDA approved and commercially available though its use in this study is investigational A maximum of 5 patients will be treated on this protocol All will be enrolled at M D Anderson
Before treatment starts participants will have at least one and up to three biopsyies of damaged tissue performed to find out about the severity of tissue damage A biopsy is taken with a large needle Women able to have children must have a negative blood pregnancy test
Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week This will be repeated every other week for a total of 4 weeks Blood tests about 2 teaspoons each will be performed 3 times while at M D Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range Participants will have at least one and up to three biopsyies again performed about 8 weeks after the start of rhG-CSF treatment An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it and not for research purposes only
Participants will be taken off study if severe side effects occur The study will end after the last biopsy or biopsies are taken about 3 months after the start of rhG-CSF treatment
This is an investigational study RhG-CSF is FDA approved and commercially available though its use in this study is investigational A maximum of 5 patients will be treated on this protocol All will be enrolled at M D Anderson
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