Expired Study
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Baltimore, Maryland 21225


Purpose:

The purpose of this study is to collect bone marrow cells for research purposes.


Study summary:

This study is designed to provide bone marrow cells for other research studies. The research is being done because there are ongoing experiments in a number of National Institute on Aging (NIA) laboratories that require access to normal human bone marrow aspirate for their studies of the immune system. These studies are done to understand how blood cells are formed and how they function. Samples will be used to study problems such as the immune system in bone marrow failure and related conditions. Cells will be used in laboratory research and may be banked for future laboratory studies


Criteria:

Inclusion Criteria: - Healthy volunteers age 18 and over Exclusion Criteria: - Significant abnormalities on health history questionnaire or in the results of blood tests - Pregnant or nursing mother - Participation in another research study within the past six weeks that is felt by the Principal Investigator to be incompatible with this study - Severe infection in the past two months - Immune disorder, or use of any medication that can alter immune system function - A medical or mental health finding showing inability to go through the procedure - Body mass index (BMI) greater than 29% - Chronic back pain, sciatica, or a compression fracture of the spine - Positive test results for viral infections: Hepatitis B, Hepatitis C, or HIV (AIDS)


Study is Available At:


Original ID:

AG0046


NCT ID:

NCT00183066


Secondary ID:


Study Acronym:


Brief Title:

Collection of Bone Marrow Aspirate From Volunteer Donors


Official Title:

Collection of Bone Marrow Aspirate From Volunteer Donors for In Vitro Hematopoietic Research


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dan L. Longo, MD
Principal Investigator
National Institute on Aging (NIA)

Study Dates

Start Date:July 2002
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2012
Primary Completion Type:Actual
Verification Date:August 2012
Last Changed Date:August 3, 2012
First Received Date:September 13, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Bone marrow aspirates Whole blood
Study Population: Healthy males and females 18 years and older
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Cashman J, Clark-Lewis I, Eaves A, Eaves C. Stromal-derived factor 1 inhibits the cycling of very primitive human hematopoietic cells in vitro and in NOD/SCID mice. Blood. 2002 Feb 1;99(3):792-9.
PMID:11806978
Reference Type:Reference
Citation:Exley MA, Tahir SM, Cheng O, Shaulov A, Joyce R, Avigan D, Sackstein R, Balk SP. A major fraction of human bone marrow lymphocytes are Th2-like CD1d-reactive T cells that can suppress mixed lymphocyte responses. J Immunol. 2001 Nov 15;167(10):5531-4.
PMID:11698421
Reference Type:Reference
Citation:Johnson BS, Mueller L, Si J, Collins SJ. The cytokines IL-3 and GM-CSF regulate the transcriptional activity of retinoic acid receptors in different in vitro models of myeloid differentiation. Blood. 2002 Feb 1;99(3):746-53.
PMID:11806973

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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