Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

18 años - 100 años

Sexo admitido

Todos los sexos

Voluntarios sanos

Aceptados

Participantes

5000 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

Background:

Many different research projects need a steady supply of human blood. Blood donated by screened, healthy people may be used to test new drugs, for example, or to learn how blood cells work. Scientists from the National Institutes of Health and the Food and Drug Administration want to collect blood from donors for use in laboratory studies.

Objective:

To collect blood and blood parts from healthy donors for research.

Eligibility:

Healthy people aged 18 years and older who weigh more than 110 pounds. They must meet the requirements to donate blood for research.

Participants will be screened. A nurse will check their general health. The veins in both arms will be checked to make sure they are good for donation.

Participants may donate whole blood as often as they wish, but no more than 2 cups will be taken over an 8-week period. At each visit, they will fill out a questionnaire about their health, and a small sample of blood will be tested to make sure it is safe to donate.

Participants may also opt to donate only white blood cells. They will undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.

Those who donate white blood cells called granulocytes may need to take 2 drugs, including a steroid, the day before. Participants who repeat this donation will need an eye exam.

Participants may remain in the study for 20 years.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

• INCLUSION CRITERIA:

Donors must meet the eligibility criteria for volunteer blood donation, defined in the Code of Federal Regulations 21 CFR 640 and AABB Standards as modified in the 2007 FDA/CBER Guidance Document: Eligibility Criteria for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products except for foreign travel history and other conditions outlined in exclusion criteria.

• Ability of subject to understand, ask questions, and the willingness to provide written informed consent.
• Age greater than or equal to 18 years.
• Weight is greater than 110 pounds.
• Donors who have a family history of CJD, donors who have undergone tattooing or body piercing, 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 donations on this protocol.
• Donors who have traveled to Europe, Africa, Asia, and areas of South America, who are rendered ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations
• 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 a xenotransplant are eligible for research donations.
• Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of \>= 45mL/min/1.73m\^2.

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.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

• Pregnancy.
• Known heart, lung, kidney disease, or bleeding disorder.
• History of sickle cell disease.
• 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. Deferral periods for high-risk activities (men who have sex with men (MSM), intravenous (IV) drug use or receipt of money or drugs in exchange for sex) will not exceed the corresponding deferral period as defined for allogeneic blood donors.
• History of malaria in the past 12 months.
• Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. 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 may not receive filgrastim if they have a history or symptoms of coronary heart disease.

Población del estudio

Healthy volunteer donors

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

National Institutes of Health Clinical Center (CC)

Inicio del estudio

15 nov 2026 Estimado

Finalización primaria

7 ago 2046 Estimado

Finalización del estudio

7 ago 2046 Estimado

Primera publicación

16 oct 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio