Collection of Bone Marrow Aspirate From Normal Volunteers

Recruiting now

Conditions studied: Normal Aging

In brief

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.

Key facts

Study ID

NCT03949647

Run by

National Institute on Aging (NIA)

People needed

2000

Starts

2019-05-08

Expected to finish

2050-12-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: accepted.

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.
• Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials.
• Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal or for joint injection.
• Hepatitis B immune globulin: Volunteers are deferred 6 months if given after exposure to hepatitis B to ensure the volunteer has not been infected. If administered for prophylaxis, no deferral is necessary.
• Live Attenuated Virus Vaccinations: Defer for 4 weeks if symptom-free.
• Inactivated (Killed Virus) Vaccinations: Defer for 2 weeks if symptom-free.
• Rabies Vaccine: Deferred for 1 year if given for rabies exposure; otherwise accept immediately if symptom-free.
• Smallpox Vaccine: Deferred until the scab has separated from the skin spontaneously or 21 days from date of immunization, whichever is longer, if volunteer had no other symptoms or complications. Visual verification of absence of vaccine scab is required. If scab was otherwise removed (not spontaneously separated), defer for 2 months after vaccination date.
• Experimental Medication or Unlicensed (Experimental) Vaccine is usually associated with a research protocol and the effect on bone marrow is unknown. Deferral is one year unless otherwise indicated by the Principal Investigator.
• Infection or Fever: Deferred until 2 weeks after antibiotics are completed and volunteer is feeling well.
• Surgical Procedures: Deferred for 3 months after procedure and released to return to normal activities by primary care physician or surgeon.

Where it is running

• National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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