Tissue Repair in Stem Cell Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501228
Recruitment Status : Terminated
First Posted : July 16, 2007
Results First Posted : November 20, 2009
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 12, 2007
July 16, 2007
March 3, 2009
November 20, 2009
August 7, 2012
February 2003
September 2008   (Final data collection date for primary outcome measure)
Number of Donor Derived Cells After G-CSF Therapy [ Time Frame: Baseline + 8 Weeks post transplant ]
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.
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Complete list of historical versions of study NCT00501228 on Archive Site
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Tissue Repair in Stem Cell Transplant Recipients
RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients

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.

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 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) 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.

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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Graft-Versus-Host Disease
Drug: Filgrastim
5 mg/kg ID Once Daily x 1 Week
Other Name: RhG-CSF
Experimental: Filgrastim Injections
Intervention: Drug: Filgrastim
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
  2. Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
  3. Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
  4. Donors and patients must be of different gender.
  5. 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.
  6. The only acceptable consent form is the one attached at the end of this protocol.
  7. Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.

Exclusion Criteria:

  1. Patients who are allergic to rhG-CSF.
  2. 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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Principal Investigator: Martin J. Korbling, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP