Collection of Bone Marrow Aspirate From Normal Volunteers
ConditionNormal Aging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Institute on Aging (NIA)
About this trial
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
This trial accepts healthy volunteersQualifiers
Normal healthy males and females, age 18 years and older.
Agree to DNA/RNA extraction of collected samples, and analysis and storage.
Health History Questionnaire, based on the American Association of Blood Banks (AABB) guidelines (Attachment 3), is not remarkable for active infection or HIV risk.
Able to speak and read English.
Disqualifiers
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.
Unable to provide informed consent
Allergy to Lidocaine (numbing agent) used during bone marrow aspiration procedure
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.
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: 1
Trial outcomes
Primary outcomes
1
Collect bone marrow aspirate for distribution to NIA research investigators for their studies.
We will need to maintain an active volunteer pool of approximately 200 active volunteers.
Time frame
Longitudinal studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov