Peripheral blood stem cells for allografting.
J Goldman
https://pubmed.ncbi.nlm.nih.gov/7534129Actively Recruiting
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID00001529
Use of G-CSF Mobilized Blood Cells From Healthy Volunteers to Develop Improved Stem Cell and Lymphocyte Selection Methods for Allogeneic Transplantation to Reduce Graft-Versus-Host Disease
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
Researchers are studying ways to improve bone marrow transplant methods to treat blood disorders like leukemia while reducing serious complications such as graft-versus-host disease (GVHD). GVHD occurs when donor white blood cells attack the recipient's tissues, which can be fatal. This study focuses on using a growth factor called granulocyte colony stimulating factor (G-CSF) to mobilize stem cells from healthy donors' blood and then remove the white blood cells that cause GVHD, aiming to make transplants safer and more effective. Volunteers will receive daily injections of G-CSF to increase the number of stem cells in their blood. Blood cells are then collected through a procedure called apheresis, where white blood cells (lymphocytes) are removed while preserving the stem cells needed for healthy blood production. This process will be studied and improved using cells collected from healthy donors. The research also examines how G-CSF affects lymphocyte function, which may influence immune responses after transplantation. Participants will undergo screening to confirm health status and blood vessel suitability for apheresis. During the study, they will be monitored for reactions to G-CSF and have blood samples collected for analysis. Researchers will evaluate stem cell counts, lymphocyte function, and other laboratory measures to develop better cell selection methods. The goal is to provide safer transplant options by optimizing the collection and processing of stem cells from healthy donors.
CONDITIONS
Official Title
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
R
Richard A Gustafson, R.N.
A
Andre Larochelle, M.D.
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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Published Research Related To This Trial
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A P Grigg, A W Roberts, H Raunow...
https://pubmed.ncbi.nlm.nih.gov/8541532Positive selection of CD34+ hematopoietic cells using an immunoaffinity column results in T cell-depletion equivalent to elutriation.
M Cottler-Fox, K Cipolone, M Yu...
https://pubmed.ncbi.nlm.nih.gov/7534711