- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442195
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Procurement and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers to Support Clinical and Translational Research Projects in the NHLBI
The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.
Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:
- Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.
- Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.
- Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: OPR Office of Patient Recruitment
- Phone Number: (800) 411-1222
- Email: ccopr@nih.gov
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Phone Number: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Self-declared healthy volunteer (for blood and buccal mucosa sample donors).
Be healthy, as determined by Principal Investigator or designee based on recent (<3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).
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Age 8 years and older (no upper limit) for blood and buccal mucosa sampling.
OR
Ages 18 years or older (no upper limit) for bone marrow or skin tissue sampling.
EXCLUSION CRITERIA:
Unable to comprehend the investigational nature of the protocol participation.
CBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).
Pregnancy
Age less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.
Off campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Healthy Volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To obtain blood, bone marrow, and skin punch biopsy samples and/or buccal mucosa samples from subjects seeking to participate as healthy volunteers in NIH laboratory research studies.
Time Frame: Ongoing
|
Ongoing
|
Collaborators and Investigators
Investigators
- Principal Investigator: Neal S Young, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 070113
- 07-H-0113
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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