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A Study of Stem Cells and Filgrastim | Clinical Trials | Clareo Health

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A Study of Stem Cells and Filgrastim

A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim

NCT00001071•National Institute of Allergy and Infectious Diseases (NIAID)

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Concurrent Medication:
•Allowed:
•PCP prophylaxis.
•Antiretroviral therapy in patients with CD4 counts \<= 500 cells/mm3.
•Narcotic analgesics for grade 3/4 bone pain toxicity.
•Patients must have:
•HIV infection.
•HIV infected patients with CD4 count \> 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count \< 200 cells/mm3 may or may not have AIDS-defining conditions.
•No antiretroviral therapy within the past 30 days in patients with asymptomatic disease and CD4 count \> 500 cells/mm3.
•Stable antiretroviral therapy for the past 60 days if CD4 count \<= 500 cells/mm3.
+4 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with the following symptoms or conditions are excluded:
•Current malignancy.
•Any medication condition that interferes with study evaluation.
•Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones).
•Concurrent Medication:
•Excluded:
•Acute treatment for serious opportunistic infection.
•Systemic cytotoxic chemotherapy.
•Concurrent Treatment:
+12 more criteria

Locations (2)

UCLA CARE Center CRS

Los Angeles, California, United States

University of Colorado Hospital CRS

Aurora, Colorado, United States

Key Dates

Completion Date

October 1, 1998

Last Updated

November 4, 2021

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Filgrastim

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Stem Cells and Filgrastim

Inclusion Criteria

Exclusion Criteria

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