Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
Recruiting
Phase 3
Interventional Study
Healthy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 60,000 (estimated)
- Sponsor
- Center for International Blood and Marrow Transplant Research · Research network
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About This Trial
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 reci…
Trial Locations
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Eligibility Criteria
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 re…
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