Actively Recruiting
Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-01
850
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The research goal of this study is to obtain CD34+ hematopoietic stem cells (HSC) from peripheral blood and/or bone marrow, and Mononuclear Cells (lymphocytes and monocytes), and granulocytes (grans) from peripheral blood that will be used in the laboratory and/or in the clinic to develop new cell therapies for patients with inherited or acquired disorders of immunity or blood cells. Development of novel cellular therapies requires access to HSC, Mononuclear Cells and/or granulocytes as the essential starting materials for the pre-clinical laboratory development of gene therapies and other engineered cell products. HSC or blood cells from healthy adult volunteers serve both as necessary experimental controls and also as surrogates for patient cells for clinical scale-up development. HSC or blood cells from patients serve both as the necessary experimental substrate for novel gene therapy and cellular engineering development for specific disorders and as pre-clinical scale up of cellular therapies. Collection of cells from adult patients collected in the NIH Department of Transfusion Medicine (DTM) under conditions conforming to accepted blood banking clinical practice may also be used directly in or cryopreserved for future use in other NIH protocols that have all required regulatory approvals allowing such use. In summary, the research goal of this protocol is the collection of HSC or blood cells that may be used for both laboratory research and/or for clinical treatment in other approved protocols.
CONDITIONS
Official Title
Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Patients with genetically defined primary immune deficiency (PID) or clinical history suggestive of PID or other blood disorders
- Patients with preserved kidney function (creatinine 64; 2.5 mg/dL, proteinuria 64; 3+), liver function (bilirubin 64; 2.0 mg/dL), and blood counts (WBC 64; 1000/mm�b3, granulocytes 64; 500/mm�b3, platelets 64; 100,000, hematocrit 64; 25)
- Patients with stable chronic thrombocytopenia may be eligible with investigator approval
- Patients of childbearing potential must use effective contraception and have a negative pregnancy test before G-CSF administration
- Willingness to allow blood cell samples to be stored and modified to induced pluripotent stem cells (iPS cells)
- Healthy adults aged 18 to 65 years without active infection or history of recurrent infection
- Healthy volunteers weighing at least 50 kg
- Healthy volunteers with normal kidney (creatinine 64; 1.5 mg/dL, proteinuria 64; 1+), liver (bilirubin 64; 1.5 mg/dL), and blood counts (WBC 64; 2500/mm�b3, granulocytes 64; 1200/mm�b3, platelets 64; 120,000, hematocrit 64; 38)
- Healthy female volunteers of childbearing potential must use effective contraception and have a negative pregnancy test before G-CSF administration
- Adults with known genetic mutations may participate as healthy volunteers for research if other criteria are met
You will not qualify if you...
- Patients who are hemodynamically unstable or require mechanical respiratory assistance
- Female patients who are pregnant or breastfeeding
- Patients positive for certain infections unless special testing determines safety
- Healthy volunteers with active bacterial, fungal, or viral infection, fever over 38deg;C, or high white blood cell count (>9000)
- Healthy volunteers who are pregnant or breastfeeding
- Healthy volunteers without adequate peripheral venous access for apheresis
- Healthy volunteers deemed by investigator to be at undue risk
- Patients unable to lie prone or tolerate general anesthesia for bone marrow harvesting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joanna L Peterson
CONTACT
H
Harry L Malech, 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
2
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