Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Ce… (NCT00001405) | Clinical Trial Compass
RecruitingNot Applicable
Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes
United States850 participantsStarted 1994-02-27
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Exclusion criteria
✕. Patients who are hemodynamically unstable (systolic or diastolic blood pressure fall of 20 mm Hg from the stable patient s baseline measurement) or requiring mechanical respiratory assistance are excluded.
✕. Female patients who are pregnant or lactating as determined by history and/or positive pregnancy test are excluded.
✕. Must be negative by routine blood donor eligibility testing criteria including tests for syphilis (RPR) and TTV Donor Transplant Panel testing (list is modified periodically, but may include hepatitis B and C, HIV and HTLV, T. cruzi). This does not apply to leukapheresis patients, as these tests are not required by DTM.
✕. XSCID patients do not make antibodies and false positives may occur because they receive periodic infusions of pooled donations of IVIG. We have observed positive anti-HBc testing in these patients. If this occurs, more specific DNA or antigen testing will be done and must be negative.
✕. Patients with CGD and other patients with autoimmunity as part of their PID phenotype may have false positive antibody tests and if this occurs more specific DNA or antigen testing will be done and must be negative.
✕. Autologous HSC Transplant patients - may be positive for Hepatitis B and C if the investigator deems it necessary to be collected and used as a safety back-up
✕. Active bacterial, fungal or viral infection as evidenced by history, physical exam (temperature \>38 degress C), or WBC \>9000 are excluded.
What they're measuring
1
Mobilize to peripheral blood and apheresis collect CD34+PBSC of PID patients for clinical treatment and in part (or entirely) for laboratory research
Timeframe: 1/1/2025
2
Mobilize to the peripheral blood and apheresis collect CD34+PBSC from healthy volunteers for research
Timeframe: 1/1/2025
3
Mobilize to peripheral blood mononuclear cells and granulocytes
Timeframe: 1/1/2025
4
bone marrow harvest
Timeframe: 1/1/2025
5
bone marrow by needle aspiration
Timeframe: 1/1/2025
6
laboratory studies of PBSC and bone marrow HSC
Timeframe: 1/1/2025
7
laboratory studies of mononuclear cells and granulocytes obtained from patients with PID or healthy volunteers
Timeframe: 1/1/2025
Trial details
NCT IDNCT00001405
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)