RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
It has been found that cells circulating in the blood are capable of forming cells lining
the oral cavity, skin cells, and/or 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) biopsy(ies)
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
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) biopsy(ies) 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Donor Derived Cells After G-CSF Therapy
In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.
Baseline + 8 Weeks post transplant
Martin J. Korbling, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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