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Recruiting NCT03949647

Collection of Bone Marrow Aspirate From Normal Volunteers

Conditions: Normal Aging

Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: Yes
Enrollment: 2000
Sponsor: National Institute on Aging (NIA)

Location: National Institute of Aging, Clinical Research Unit Baltimore Maryland

Summary

Background: 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. Objective: To understand how progenitor cells change with age. Eligibility: Healthy people ages 18 and older Design: 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. ...

Eligibility Criteria

* INCLUSION CRITERIA: 1. Normal healthy males and females, age 18 years and older. 2. Agree to DNA/RNA extraction of collected samples, and analysis and storage. 3. Health History Questionnaire, based on the American Association of Blood Banks (AABB) guidelines (Attachment 3), is not remarkable for active infection or HIV risk. 4. Able to speak and read English. 5. Willingness and ability to come to the NIA Clinical Research Unit at MedStar Harbor Hospital in Baltimore every 2 years for a bone marrow aspiration procedure. EXCLUSION CRITERIA: 1. Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required. 2. Unable to provide informed consent 3. Allergy to Lidocaine (numbing agent) used during bone marrow aspiration procedure 4. Test results are positive for viral infections such as RPR, HIV, Hepatitis B surface antigen or hepatitis C antibodies. For participants who have been treated for Hepatitis C, screening blood work must show HCV RNA quantitative is not detectable. Researchers are seeking healthy, pristine cells. Due to the ongoing nature of these chronic viral and bacterial infections, the blood cell populations will change. Researchers want to study changing cell populations as a factor of aging only and not those altered by infections. 5. Ongoing risk factors for HIV or Hepatitis B or C such as: intravenous drug use, non-monogamous unprotected intercourse. These viruses weaken the immune system and cause changes in the white blood cells and their progenitors. 6. Major medical illnesses such as any type of liquid or solid tumor cancer, history of deep vein thrombosis, auto-immune disorders, organ or bone marrow transplant, or liver, kidney, heart or lung disease. 7. A medical finding that shows a participant could not safely go through this procedure. (such as Parkinson s disease, dementia or any uncontrolled behavior that would place the participant s safety at risk) 8. Bleeding conditions such as hemophilia or von Willebrand s disease. 9. Significant abnormalities are found in the results of blood tests such as elevated liver enzymes (2x normal for MedStar Harbor Hospital Clinical Laboratory parameters), abnormal kidney function, positive viral titers, GFR \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03949647). StuddyBuddy aggregates publicly available trial information.