Collection of Bone Marrow Aspirate From Normal Volunteers
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|ClinicalTrials.gov Identifier: NCT03949647|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : November 15, 2019
Bone marrow is the soft material found inside most large bones of the body. Bone marrow produces red blood cells, white blood cells, and platelets that are released into the blood stream. Inside the marrow, these cells start off as young, immature cells called progenitor cells. Researchers want to study these cells in healthy people.
To understand how progenitor cells change with age.
Healthy people ages 18 and older
Participants will be screened with a questionnaire, a physical exam, and blood tests.
Participants will have a bone marrow aspirate. They will be asked to lie on their stomach or side. A local anesthetic will be injected with a small needle under the skin at the site. A needle will then be placed through the skin and into the hip bone. A small amount of the liquid part of the bone marrow will be taken up into the needle. After the needle is removed, a pressure bandage will be placed on the site.
Participants will be asked to become a repeat volunteer and have a bone marrow aspirate sample collected once every other year. They will have a physical exam and blood tests before each collection.
The cells from the collection will be used for genetic testing and research.
Participants will be in the study for as long as they remain healthy and willing to participate.
|Condition or disease|
Bone marrow is soft tissue found inside the large bones of the body. Bone marrow produces red blood cells, white blood cells, and platelets that are eventually released into the blood stream. These three cell types are considered mature cells (adult cells) and they come from a progenitor cell that lives in the bone marrow. This study is designed to provide bone marrow aspirate and blood cells for research studies by basic investigators within NIA. Volunteers are screened by a health history questionnaire, a physical examination by the principal investigator, and blood tests to detect any obvious blood diseases, or bleeding or immune disorders. A bone marrow aspirate procedure is performed using a needle inserted into the hip bone to withdraw a small amount of fluid from the bone marrow for studies. NIA Researchers will use these samples for in vitro research only. In other words, these cells are never given back to a human. We will not share samples or data with researchers outside NIH.
The study population consists of healthy males and females aged 18 years and older. Study subjects are anticipated to be non-patient community volunteers. Individuals will not be excluded based on gender, race, or ethnicity. The number of subjects to be enrolled will be 2000. This will allow us to try and maintain 200 active participants in this protocol. Volunteers are screened initially and once every 2 years while on-study by a health history questionnaire and laboratory testing. Although participants may undergo a bone marrow aspirate procedure every 56 days in clinical practice, it is our plan to collect longitudinal data and obtain one sample once every other year.
We will collect bone marrow aspirate samples for distribution to NIA research investigators for their studies of the aging process in progenitor cells. We will be performing bone marrow aspirate collections of 1-5 samples every other week. We will need to maintain an active volunteer pool of approximately 200 active volunteers.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Collection of Bone Marrow Aspirate From Normal Volunteers|
|Estimated Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||December 31, 2050|
|Estimated Study Completion Date :||December 31, 2050|
Healthy males and females aged 18 years and older
- Collect bone marrow aspirate for distribution to NIA research investigators for their studies. [ Time Frame: Longitudinal study ]We will need to maintain an active volunteer pool of approximately 200 active volunteers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949647
|Contact: Julia L McKelvey, R.N.||(410) firstname.lastname@example.org|
|United States, Maryland|
|National Institute of Aging, Clinical Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: NIA Studies Recruitment 410-350-3941 email@example.com|
|Principal Investigator:||Josephine M Earley, M.D.||National Institute on Aging (NIA)|