A Study of Stem Cells and Filgrastim
To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim|
|Study Completion Date:||October 1998|
Patients and volunteers receive seven daily subcutaneous injections of G-CSF. On days 5 and 6 of drug administration, patients have peripheral blood mononuclear cells harvested by leukapheresis. HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms. If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort, then the last three patients in that cohort will receive a dose escalation. Patients are followed for 24 weeks.
|United States, California|
|UCLA CARE Center CRS|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|University of Colorado Hospital CRS|
|Aurora, Colorado, United States|
|Study Chair:||Schooley R|
|Study Chair:||Miles S|
|Study Chair:||Pomerantz R|