Tissue Repair in Stem Cell Transplant Recipients

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Amgen
• Treatments: Lenograstim

Criteria

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.