Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products
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|ClinicalTrials.gov Identifier: NCT01071577|
Recruitment Status : Suspended
First Posted : February 19, 2010
Last Update Posted : March 29, 2018
- Bone marrow stromal cells (BMSCs) can be grown from bone marrow provided by healthy volunteers. Volunteer bone marrow donors for BMSCs are generally required to meet the same healthy history and infectious disease marker screening criteria as volunteer blood donors. BMSCs are being used to treat a number of immune system and cardiovascular disorders, including graft-versus-host disease (GVHD), heart disease, and vascular disease. The National Institutes of Health Clinical Center is interested in collecting bone marrow aspirates and biopsies from healthy volunteers to produce clinical-grade BMSCs to treat Clinical Center patients.
- This study will also collect bone marrow from autologous donors (donors who will later receive their own BMSCs) for further treatment.
- To collect bone marrow aspirates and biopsies from healthy subjects and autologous donors in order to produce BMSCs.
- Individuals at least 18 years of age who are either healthy volunteers or individuals who will need to receive their own BMSCs.
- Prospective healthy volunteers will be asked a series of questions designed to identify exposure to human immunodeficiency virus (HIV), hepatitis B or C, or other transfusion-transmitted diseases. A blood sample will be collected and tested for the abovementioned diseases and for other problems that may prevent bone marrow donation.
- Prospective autologous donors will also have blood tests to evaluate their own suitability for bone marrow donation.
- Eligible participants will be scheduled to provide a marrow aspirate/biopsy, taken from the upper part of the thigh bone, using standard bone marrow donation techniques.
- The collected bone marrow will be processed into BMSCs at the National Institutes of Health.
|Condition or disease|
|Bone Marrow Bone Marrow Stromal Cells Mesenchymal Stem Cells Blood Donors|
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Official Title:||Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products|
|Study Start Date :||January 27, 2010|
- (Update as necessary - The date that the final subject will be examined or an intervention received for thepurposes of final collection of data for the primary outcome.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071577
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||David F Stroncek, M.D.||National Institutes of Health Clinical Center (CC)|