Improving collection of white blood cells from healthy donors
Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone
This study is testing if giving healthy volunteers special medications can help collect more effective white blood cells to support patients with low counts from treatments like chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01553214 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the collection of granulocytes, a type of white blood cell crucial for fighting infections, from healthy donors. Participants aged 18 to 75 will receive injections of filgrastim and dexamethasone to mobilize these cells into the bloodstream for collection via apheresis. The study will monitor the effects of these medications and the donation process on the volunteers. The goal is to improve the quantity and quality of granulocytes collected, which can benefit patients with low white blood cell counts due to conditions like chemotherapy or bone marrow transplants.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 75 who meet all donor eligibility criteria.
Not a fit: Patients with uncontrolled hypertension or certain past medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve infection-fighting capabilities in patients with low granulocyte counts.
How similar studies have performed: Previous studies have shown that using G-CSF in combination with corticosteroids can significantly increase granulocyte collection, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet the following restrictions: * Age greater than or equal to18 and less than or equal to 75 years * If hypertension is present, must be well-controlled on medications * If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications * If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The only exception to this is a history of bilateral cataract extractions due to PSC. EXCLUSION CRITERIA: * Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR. * Weight less than 50 kg (110 lbs). * History of coronary heart disease * Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100) * Diabetes mellitus requiring insulin * Active, symptomatic peptic ulcer disease * History of iritis or episcleritis * Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required. * Lithium therapy * Pregnancy or nursing (breast feeding) * Renal function eGFR \< 45 ml/min/1.73m(2)
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Leonard N Chen, M.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Tania M Scinto
- Email: ts297r@nih.gov
- Phone: (301) 496-9702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.