Recruiting
Phase 3

Filgrastim-Mobilized Stem Cells

Sponsor:

Center for International Blood and Marrow Transplant Research

Code:

NCT00785525

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Filgrastim

Study Details

Brief summary:

The purpose of the study is to:

  • Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors
  • Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
  • Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients
  • Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Conditions

Healthy

Study ID

NCT00785525

Start date

Feb, 1997

Status verified date

Jan, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
2. Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more than one test to be performed.

Exclusion Criteria:

1. Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.
2. Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
3. History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
4. History of deep vein thrombosis or pulmonary embolism.
5. History of iritis or episcleritis.
6. Thrombocytopenia < 150 x 10\^9/L (< 150,000/uL) at baseline evaluation.
7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
8. Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test.
9. Donors receiving experimental therapy or investigational agents.
10. Positive pregnancy test collected/reported prior to start of filgrastim.

Study Design

Enrollment

60000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Interventions

Filgrastim

PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.

Primary outcome measure

  • Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

Gift of Life Bone Marrow Foundation

Recruiting

Boca Raton, Florida, United States, 33431

C.W. Bill Young Marrow Donor Center

Recruiting

Rockville, Maryland, United States, 20852

Principal Investigator:

Michael Donnelly, MD

Be The Match

Recruiting

Minneapolis, Minnesota, United States, 55401

DKMS Americas

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

Center for International Blood and Marrow Transplant Research

Last update posted

Apr 13, 2025

Last verified

Jan, 2025

Keywords

  • Healthy Unrelated Stem Cell Donors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research on 2025-04-13.