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 Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-05
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 transplants for blood disorders like leukemia. A serious complication called graft-versus-host disease (GVHD) can occur when donor immune cells attack the recipient's tissues. To reduce this risk, the study is exploring a method that uses peripheral blood stem cells from donors, removing the white blood cells that cause GVHD while keeping the stem cells needed for healthy blood production. The study also looks at how a growth factor called G-CSF affects the immune cells involved in transplantation. The study involves healthy volunteers who receive daily injections of G-CSF to stimulate the production of stem cells. Blood cells are then collected through a process called apheresis, and the white blood cells (lymphocytes) are selectively removed to create a safer transplant product. The collected stem cells will be studied to refine the methods of cell processing and to understand the interactions between stem cells and lymphocytes. This observational study uses samples from healthy donors to develop better transplantation techniques. Participants will be monitored during G-CSF injections and blood collection. Researchers will analyze the collected cells for their ability to support blood cell growth and their surface markers. They will also study the effects of G-CSF on lymphocyte function. The main goal is to provide a source of primitive blood-forming cells for laboratory research and to improve methods that safely remove harmful lymphocytes while preserving stem cells. The study includes screening for health status and blood vessel suitability to ensure participant safety.
CONDITIONS
Brief 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 individual aged 18 to 60 years
- No active infection or history of recurrent infection
- Normal kidney function: creatinine less than 1.5 mg/dL or estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 or higher, with no significant proteinuria
- Normal liver function: bilirubin less than 2.0 mg/dL (when unconjugated), transaminases less than 2 times the upper limit of normal without known liver disease
- Normal blood counts: WBC 2,500-11,000/microliter, ANC above 1,500/microliter, platelets above 150,000/microliter, hemoglobin above 12.0 g/dL
- Normal cardiovascular function with no history of chest pain, heart attack, peripheral vascular disease, transient ischemic attack, or stroke
- Healthy females of childbearing age must have a negative pregnancy test within one week before starting G-CSF
- Female subjects should not be breastfeeding
- Eligible for normal blood donation and negative tests for syphilis, hepatitis B and C, HIV, HTLV-1, West Nile virus, T. Cruzi, and Babesia
- Able to understand the study and give informed consent
- Adequate veins for blood collection during apheresis as confirmed by nurse screening
You will not qualify if you...
- Active viral, bacterial, fungal, or parasite infection
- Female who is pregnant or breastfeeding
- Active or moderate-to-severe autoimmune disease needing immunosuppressive therapy; stable mild autoimmune disease may be considered case-by-case
- Active or recent cancer within the past 5 years, except certain low-risk cancers in remission
- History of blood disorders
- Significant cardiovascular disease such as symptomatic coronary artery disease or uncontrolled hypertension; minor risks evaluated case-by-case
- Any positive results on required infectious disease screening tests
- Allergy to G-CSF or bacterial E. coli products
- Use of NSAIDs within 5 to 7 days before starting the study
- Previous G-CSF administration and leukapheresis within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Mobilization
Duration - Approximately 5 days
Participants receive daily injections of G-CSF to mobilize stem cells into the bloodstream. The first dose is given at the clinic with monitoring, and subsequent doses may be self-administered at home or given at the clinic.
1 initial monitored visit and daily injections for up to 5 days
Leukapheresis Collection
Duration - 1 to 2 days
Participants undergo apheresis to collect mobilized stem cells and lymphocytes for laboratory studies.
1 to 2 apheresis visits
Sample Storage and Analysis
Duration - Variable, according to laboratory schedules
Collected cells are stored and analyzed in the laboratory to develop improved methods of stem cell and lymphocyte selection for transplantation research.
No participant visits required
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
Optimizing dose and scheduling of filgrastim (granulocyte colony-stimulating factor) for mobilization and collection of peripheral blood progenitor cells in normal volunteers.
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