Improving White Blood Cell Collection From Healthy Donors

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Mar 10, 2012

Keywords

ClinConnect Summary

This clinical trial is studying how to improve the collection of a type of white blood cell called granulocytes from healthy volunteers. Granulocytes are important for fighting infections, especially in patients who have had chemotherapy or bone marrow transplants, as they often have low levels of these cells. The trial aims to find the best methods to gather these cells, using two medications—filgrastim and dexamethasone—that help increase the number of granulocytes in the bloodstream before donation.

To participate, individuals must be healthy adults aged between 18 and 75 years. Participants will undergo a screening process to ensure they meet specific health criteria. If eligible, they can donate granulocytes through a process called apheresis, which takes about two hours, and can do this up to 12 times in a year, with at least four weeks between donations. The trial is currently recruiting volunteers, and participants can withdraw from the study at any time if they choose. It's a great opportunity to help patients in need while also contributing to important research.

Gender

ALL

Eligibility 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)
• • History of hepatitis or injection drug use
• • 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)