Bethesda, Maryland 20892


Purpose:

This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors. 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


Study summary:

Background: -NIH and FDA intramural investigators performing in vitro studies involving human blood components have a need for a steady, reliable, consistent source of these blood components, preferably derived from screened donors documented to be free of potential transfusiontransmissible diseases. Objectives: - To provide a mechanism, that is reviewed and approved by IRB, for the Department of Transfusion Medicine, Clinical Center to collect and process blood and blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA laboratories for in vitro research use. - To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling, and protection of the study subjects (research blood donors) from research risks is performed in accordance with IRB, OPRR and other applicable Federal regulatory standards. Eligibility: Donors must meet the eligibility criteria for volunteer whole blood donation with the exception of foreign travel history and other requirements, some of which are outlined below: - Age greater than or equal to 18 years - Weight greater than 110 pounds - No known heart, lung, kidney disease, or bleeding disorders - No history of sickle cell disease - Female subjects should not be pregnant Design: - Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. - The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. - Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. - NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. - 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.


Criteria:

- INCLUSION CRITERIA: Donors must meet the eligibility criteria for volunteer whole blood donation defined in the Standards of the AABB2 and the Code of Federal Regulations 21 CFR 640,3 as modified in the 2007 FDA/CBER guidance document on eligibility criteria for donors of human cells and cellular-based products,5 with the exception of foreign travel history and other disorders conditions as noted below. Ability of subject to understand and the willingness to sign the written informed consent document Age greater than or equal to 18 years. Weight greater than 110 pounds. EXCLUSION CRITERIA: No known heart, lung, kidney disease, or bleeding disorders. No history of sickle cell disease. No history of intravenous injection drug use in the past 5 years. No receipt of money or drugs in exchange for sex in the past 5 years. No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. No history of MSM in the past 5 years Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch 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 may not receive filgrastim if they have a history or symptoms of coronary heart disease. Female subjects should not be pregnant. Note: Donors who have traveled to Europe, Africa, Asia, and areas of South America that render them ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations. Donors with a history of malaria, donors who have a family history of CJD, donors who have undergone tattooing or body piercing within the prior 12 months, donors who have received a graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis in the last 12 months, are similarly eligible for research-use only donation on this protocol. Donors with a positive antibody to hepatitis B core antigen 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 plasma or leukocyte collection specifically because they were given this drug, agent, or vaccine, are acceptable if their research product is collected for use only 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 xenotranplant are eligible for research donations.


NCT ID:

NCT00001846


Primary Contact:

Principal Investigator
Kathleen A Cantilena, M.D.
National Institutes of Health Clinical Center (CC)

Amy Melpolder
Phone: (301) 496-0092
Email: amelpolder@mail.cc.nih.gov


Backup Contact:

Email: ccantilena@mail.nih.gov
Kathleen A Cantilena, M.D.
Phone: (301) 451-8637


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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