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New treatment option for Healthy
Official title Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
ClinicalTrials.gov ID: NCT00785525
What this study is testing
What is Filgrastim?
Filgrastim is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
Also referred to as Neupogen®, GCSF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
- Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more...
You likely can't join if
- Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be...
- Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
- History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history...
- History of deep vein thrombosis or pulmonary embolism.
- History of iritis or episcleritis.
- Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation.
See the full eligibility criteria
- PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
- 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.
- 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...
- Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
- 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...
- History of deep vein thrombosis or pulmonary embolism.
- History of iritis or episcleritis.
- Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation.
- Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
- Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test.
- Donors receiving experimental therapy or investigational agents.
- Positive pregnancy test collected/reported prior to start of filgrastim.
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
- Rockville, Maryland, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States; Rockville, Maryland, United States; Minneapolis, Minnesota, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.