Actively Recruiting
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-04-28
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
N
New York Genome Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old. One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death. In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD. The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells. In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells. The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.
CONDITIONS
Official Title
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals aged 18 to 60 years
- No active infection or history of recurrent infections
- Normal kidney function with creatinine less than 1.5 mg/dL or estimated glomerular filtration rate (eGFR) at least 60 mL/min/1.73 m^2 and no significant proteinuria
- Normal liver function with bilirubin less than 2.0 mg/dL (if unconjugated) and transaminases less than twice the upper limit of normal without known liver disease
- Normal blood counts: white blood cells 2,500-11,000/microliter, absolute neutrophil count above 1,500/microliter, platelets above 150,000/microliter, hemoglobin above 12.0 g/dL
- Normal heart and blood vessel function with no history of chest pain, heart attack, peripheral vascular disease, stroke, or transient ischemic attack
- Healthy females of childbearing age must have a negative pregnancy test within one week before starting G-CSF
- Female participants must not be breastfeeding
- Eligible for normal blood donation and tested negative for syphilis, hepatitis B and C, HIV, HTLV-1, West Nile virus, Trypanosoma cruzi, and Babesia
- Able to understand the study and give informed consent
- Adequate veins for peripheral blood collection during apheresis, confirmed by an apheresis nurse
You will not qualify if you...
- Active viral, bacterial, fungal, or parasitic infection
- Positive pregnancy test or currently breastfeeding
- Active or moderate-to-severe autoimmune disease requiring or expected to require immunosuppressive treatment (stable mild autoimmune disease considered case-by-case)
- Active or recent cancer within past 5 years (remote low-risk cancers in remission may be allowed)
- History of blood disorders
- Significant cardiovascular disease such as symptomatic coronary artery disease or uncontrolled high blood pressure (minor risk factors evaluated case-by-case)
- Any positive infectious disease screening test as required
- Allergy to G-CSF or bacterial E. coli products
- Use of NSAIDs within 5-7 days before starting the study depending on drug half-life
- Previous G-CSF administration and leukapheresis within the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
R
Richard A Gustafson, R.N.
CONTACT
A
Andre Larochelle, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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