Tissue Repair in Stem Cell Transplant Recipients
Stopped early · Not applicable
Conditions studied: Graft-Versus-Host Disease
In brief
Primary Objective: 1\. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial 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 epithelial/endothelial or solid organ-specific tissue.
Key facts
- Study ID
- NCT00501228
- Run by
- M.D. Anderson Cancer Center
- People needed
- 2
- Starts
- 2003-02-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2012-08-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
- Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
- Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
- Donors and patients must be of different gender.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
- The only acceptable consent form is the one attached at the end of this protocol.
- Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.
You may not qualify if…
- Patients who are allergic to rhG-CSF.
- Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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