Collection of Bone Marrow Aspirate From Normal Volunteers

NCT03949647 | Recruiting

• 2 other identifiers: 99991909019-AG-N090
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Aging

Keywords

LGR; Aging; CD44; Stem Cells; Progenitor Cells; Natural History

Outcome Measures

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.

  Longitudinal study

Study Arms (1)

1

Healthy males and females aged 18 years and older

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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)
• Bleeding conditions such as hemophilia or von Willebrand s disease.
• 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 \<30.
• On any medication that can alter blood cell function such as chronic steroid use, antivirals or past or present chemotherapy (complete list located in the Cytapheresis Screening manual stored in the NIA Cytapheresis Unit).
• Radiation therapy past or present.
• Inability of researchers to access iliac crest from conditions such as wounds, rashes, or large deposits of adipose tissue that makes localization of the iliac crest difficult.
• Organ transplant or any graft such as tissue, bone or skin as we don t know how this impacts progenitor cells.
• In addition, eligible participants may not be able to participate in a specific bone marrow aspiration procedure but might be eligible at a later date. These include:
• Pregnancy and Nursing Mothers: Females who are pregnant or who have had a pregnancy in the last 6 weeks are temporarily deferred. They may resume participation in the study 6 weeks after delivery or cessation of lactation and have been cleared by their obstetrician or primary care physician.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

• Tina Gupta, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri B Laporta

CONTACT

(410) 350-3929; terri.laporta@nih.gov

Tina Gupta, M.D.

CONTACT

(301) 451-0481; tina.gupta@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 14, 2019
• Study Start: May 8, 2019
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: April 8, 2026

Record last verified: 2026-03-13

Locations

US (1)