Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products
- 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.
Bone Marrow Stromal Cells
Mesenchymal Stem Cells
|Study Design:||Time Perspective: Prospective|
|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 2010|
Bone marrow stromal cells (BMSCs) can be grown from bone marrow aspirates and biopsies, and are being used to treat a number of disorders including: graft-versus-host disease (GVHD), ischemic heart disease, peripheral vascular disease and autoimmune diseases. The purpose of this protocol is to collect bone marrow aspirates and biopsies from healthy volunteers to produce clinical grade BMSCs to treat Clinical Center patients and to develop new methods for producing and assessing the quality of BMSCs. In some cases, the donors will be the recipients of the ex vivo expanded cells (autologous transplantation). In other cases, no matching of HLA or other antigens is required between the marrow donor and the BMSC recipient, so the donors will be required to meet the same healthy history and infectious disease marker screening criteria as volunteer blood donors. The BMSCs will be produced in the GMP Clinical Cell Processing Laboratory, located in the Cell Processing Section (CPS), Department of Transfusion Medicine (DTM), Clinical Center. After the BMSCs are produced by the Cell Processing Laboratory, they will be infused directly into Clinical Center patients on protocol, or cryopreserved and stored, and used as they are needed to treat Clinical Center patients. Up to 250 subjects will be enrolled in this study. This protocol will provide a mechanism for banking fresh and frozen BMSC products that can be used for patient care and research. This is not a treatment protocol. Subjects receiving these BMSC products will be enrolled in specific BMSC treatment protocols.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071577
|Contact: Lee C England, P.A.-C||(301) firstname.lastname@example.org|
|Contact: David F Stroncek, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||David F Stroncek, M.D.||National Institutes of Health Clinical Center (CC)|