A Study of Stem Cells and Filgrastim

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Center CRS
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Hospital CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Suitable venous access.

Prior Medication:

Allowed:

  • Prior antiretroviral therapy.

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:

Excluded:

  • Systemic radiation therapy.

Patients with the following prior conditions are excluded:

  • Prior malignancy.
  • Leukapheresis or lymphopheresis within the past 180 days.
  • Significant active CNS disease or seizures within the past year.

Prior Medication:

Excluded:

  • G-CSF or GM-CSF within the past 6 months.
  • Investigational antiretrovirals within the past 30 days.
  • Treatment for opportunistic infection within the past 14 days.

Active alcohol or substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Schooley R
  • Study Chair: Miles S
  • Study Chair: Pomerantz R

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 6, 2022

Primary Completion

December 6, 2022

Study Completion (Actual)

October 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 285
  • 11261 (Registry Identifier: DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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