Search / Trial NCT00001846

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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Nov 3, 1999

Trial Information

Current as of December 26, 2024

Recruiting

Keywords

Volunteer Donor Research Samples Leukapheresis Plateletpheresis Plasmapheresis Natural History

ClinConnect Summary

This clinical trial aims to collect blood components from healthy volunteer donors for research purposes. The blood will be used by scientists at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to conduct laboratory studies that help advance medical knowledge. Donors will be compensated for their time and effort, and their participation will involve a straightforward blood donation process. Before donating, participants will receive detailed information about the study, including any risks involved, and they must provide their written consent to participate.

To be eligible for this trial, donors must be at least 18 years old, weigh over 110 pounds, and meet certain health criteria, such as not having serious medical conditions or recent high-risk behaviors. Women who are pregnant cannot participate. The trial is currently recruiting participants, and it’s important to know that the blood collected will only be used for laboratory research, not for treating patients. Overall, the study is designed to ensure donor safety and comfort while contributing valuable resources for scientific research.

Gender

ALL

Eligibility criteria

  • * ELIGIBILITY 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, with the exception of foreign travel history and other conditions, as noted below:
  • Ability of subject to understand, ask questions, and the willingness to provide written informed consent
  • Age greater than or equal to 18 years
  • Weight greater than 110 pounds
  • Female subjects should not be pregnant
  • No known heart, lung, kidney disease, or bleeding disorders
  • No history of sickle cell disease
  • 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. Deferral periods for high-risk activities (MSM, 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.
  • No history of malaria in the past 12 months
  • 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 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.

Trial Officials

Kamille A West-Mitchell, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

About National Institutes Of Health Clinical Center (Cc)

The National Institutes of Health Clinical Center (CC) is the nation's largest hospital dedicated exclusively to clinical research, serving as a pivotal facility for advancing medical knowledge and innovative therapies. Located in Bethesda, Maryland, the Clinical Center provides a unique environment where patients have access to cutting-edge treatments and participate in groundbreaking clinical trials across a wide range of diseases. As a leader in translational research, the CC integrates patient care with scientific investigation, fostering collaboration among researchers, clinicians, and patients to accelerate the development of new interventions and improve health outcomes.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

AJ

GH

SC

SG

MT

5 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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