Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT00785525

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Led by Center for International Blood and Marrow Transplant Research · Updated on 2025-04-13

60000

Participants Needed

4

Research Sites

1717 weeks

Total Duration

On this page

Sponsors

C

Center for International Blood and Marrow Transplant Research

Lead Sponsor

N

National Marrow Donor Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • PBSC donors must meet the same criteria as NMDP marrow donors as set forth in the Donor Center Manual of Operations
  • Confirmatory pregnancy test must be performed within 15 days of collection and before filgrastim administration
Not Eligible

You will not qualify if you...

  • Pregnancy or uninterruptible breastfeeding; pregnancy is an absolute contraindication
  • Sensitivity to filgrastim or E. coli-derived recombinant protein products
  • History of autoimmune disorders including rheumatic diseases and thyroid disorders, except successfully treated thyroid disease
  • History of deep vein thrombosis or pulmonary embolism
  • History of iritis or episcleritis
  • Thrombocytopenia with platelet count less than 150,000/uL at baseline
  • Current treatment with lithium
  • Positive Hemoglobin-Solubility test (e.g., SickleDex)
  • Receiving experimental therapy or investigational agents
  • Positive pregnancy test prior to filgrastim start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Gift of Life Bone Marrow Foundation

Boca Raton, Florida, United States, 33431

Actively Recruiting

2

C.W. Bill Young Marrow Donor Center

Rockville, Maryland, United States, 20852

Actively Recruiting

3

Be The Match

Minneapolis, Minnesota, United States, 55401

Actively Recruiting

4

DKMS Americas

New York, New York, United States, 10016

Actively Recruiting

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Research Team

L

Lisa Erickson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

0

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