Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
NCT ID: NCT00001846
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2001-01-11
Brief Summary
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Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards...
Detailed Description
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Blood components for research use will be distributed with a unique product number, and the DTM Principal and Associate Investigators will serve as the custodians of the code that links the product with the donor s identity. The nature of the in vitro studies in which the blood and components collected on this study will be used is not the subject of this protocol, and is not possible to describe since it involves basic investigative efforts in greater than multiple different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) are performed in accordance with the Institutional Review Board (IRB), the Office of Human Subjects Research Protection (OHSRP), and other applicable Federal regulatory standards.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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research donors
healthy volunteers (age 18 years or greater) who donate blood for in vitro research purposes
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Donors with a history of repeat false positive HTLV I/II, who are rendered ineligible for allogeneic donation, are eligible for research donations.
* Donors with a positive antibody to hepatitis B core antigen (anti-HBc) only, without other positive infectious disease markers,are eligible for research donations.
* Donors with HLA antibodies are eligible for research donations
* Donors who have received an experimental drug, agent, or vaccine, and who are referred for a research blood, plasma or leukocyte collection, specifically because they were given this drug, agent, or vaccine, are acceptable only if their research product is collected for use by the PI who administered the experimental drug, agent, or vaccine. Otherwise, they are deferred for one year after receiving an experimental drug, agent, or vaccine.
* Donors who have received a xenotransplant are eligible for research donations.
* Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch (also known as hydroxyethyl starch or "HES") and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression.
* Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of \> 45ml/min/1.73m\^2.
* Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease.
Investigators are informed that eligibility standards for research donors differ from those for transfusion donors through an electronic "User Agreement" which they electronically sign when they register to receive blood components on this protocol.
18 Years
100 Years
ALL
Yes
Sponsors
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National Institutes of Health Clinical Center (CC)
NIH
Responsible Party
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Principal Investigators
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Kamille A West-Mitchell, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
References
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Maynard DM, Heijnen HF, Gahl WA, Gunay-Aygun M. The alpha-granule proteome: novel proteins in normal and ghost granules in gray platelet syndrome. J Thromb Haemost. 2010 Aug;8(8):1786-96. doi: 10.1111/j.1538-7836.2010.03932.x. Epub 2010 May 27.
Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, Heery CR, Gulley JL, Schlom J. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer. 2017 Feb 21;5:20. doi: 10.1186/s40425-017-0220-y. eCollection 2017.
Nishio K, Pasquet L, Camara K, DiSapio J, Hsu KS, Kato S, Bloom A, Richardson SK, Welsh JA, Jiang T, Jones JC, Cardell S, Watarai H, Terabe M, Olkhanud PB, Howell AR, Berzofsky JA. Lysosomal processing of sulfatide analogs alters target NKT cell specificity and immune responses in cancer. J Clin Invest. 2023 Dec 21;134(4):e165281. doi: 10.1172/JCI165281.
Dahut M, Fousek K, Horn LA, Angstadt S, Qin H, Hamilton DH, Schlom J, Palena C. Fulvestrant increases the susceptibility of enzalutamide-resistant prostate cancer cells to NK-mediated lysis. J Immunother Cancer. 2023 Sep;11(9):e007386. doi: 10.1136/jitc-2023-007386.
Han K, Singh K, Meadows AM, Sharma R, Hassanzadeh S, Wu J, Goss-Holmes H, Huffstutler RD, Teague HL, Mehta NN, Griffin JL, Tian R, Traba J, Sack MN. Boosting NAD preferentially blunts Th17 inflammation via arginine biosynthesis and redox control in healthy and psoriasis subjects. Cell Rep Med. 2023 Sep 19;4(9):101157. doi: 10.1016/j.xcrm.2023.101157. Epub 2023 Aug 15.
Cho YE, Lee H, Bae HR, Kim H, Yun S, Vorn R, Cashion A, Rucker MJ, Afzal M, Latour L, Gill J. Circulating immune cell landscape in patients who had mild ischaemic stroke. Stroke Vasc Neurol. 2022 Aug;7(4):319-327. doi: 10.1136/svn-2021-001224. Epub 2022 Mar 9.
Horn LA, Chariou PL, Gameiro SR, Qin H, Iida M, Fousek K, Meyer TJ, Cam M, Flies D, Langermann S, Schlom J, Palena C. Remodeling the tumor microenvironment via blockade of LAIR-1 and TGF-beta signaling enables PD-L1-mediated tumor eradication. J Clin Invest. 2022 Apr 15;132(8):e155148. doi: 10.1172/JCI155148.
Wu J, Singh K, Lin A, Meadows AM, Wu K, Shing V, Bley M, Hassanzadeh S, Huffstutler RD, Schmidt MS, Blanco LP, Tian R, Brenner C, Pirooznia M, Kaplan MJ, Sack MN. Boosting NAD+ blunts TLR4-induced type I IFN in control and systemic lupus erythematosus monocytes. J Clin Invest. 2022 Mar 1;132(5):e139828. doi: 10.1172/JCI139828.
Han K, Singh K, Rodman MJ, Hassanzadeh S, Wu K, Nguyen A, Huffstutler RD, Seifuddin F, Dagur PK, Saxena A, McCoy JP, Chen J, Biancotto A, Stagliano KER, Teague HL, Mehta NN, Pirooznia M, Sack MN. Fasting-induced FOXO4 blunts human CD4+ T helper cell responsiveness. Nat Metab. 2021 Mar;3(3):318-326. doi: 10.1038/s42255-021-00356-0. Epub 2021 Mar 15.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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99-CC-0168
Identifier Type: -
Identifier Source: secondary_id
990168
Identifier Type: -
Identifier Source: org_study_id