Bethesda, MDNCT01553214Now EnrollingIRB Ready

Allogeneic Granulocyte Donation Clinical Trial in Bethesda, MD

Access cutting-edge allogeneic granulocyte donation treatment through this phase 4 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institutes of Health Clinical Center (CC)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related allogeneic granulocyte donation treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Allogeneic Granulocyte Donation Study in Bethesda

Background: \- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors. Objectives: \- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation. Eligibility: \- Healthy volunteers between 18 and 75 years of age. Design: * Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility. * Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time. * Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation. * White blood cells will be collected through apheresis. The apheresis will last about 2 hours. * Participants will be eligible to donate until they reach their 76th birthday.

Sponsor: National Institutes of Health Clinical Center (CC)

Who Can Participate

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01553214) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Allogeneic Granulocyte Donation Treatment Options in Bethesda, MD

If you're searching for allogeneic granulocyte donation treatment options in Bethesda, MD, this clinical trial (NCT01553214) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced allogeneic granulocyte donation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all allogeneic granulocyte donation clinical trials near you to find additional studies recruiting in your area.

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