Acute Myocardial Infarction (AMI), Graft Versus Host Disease (GVHD)
Conditions
Keywords
MSC, Allogeneic, Bone marrow cells, Healthy subject donors, Collection of MSC from bone marrow aspirate, Bronchiolitis obliterans syndrome (BOS)
Brief summary
The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.
Detailed description
Cell banks will be manufactured and cellular products used for future translational or clinical research.
Interventions
PROCEDUREBone marrow aspirate
A single bone marrow aspirate procedure is planned.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 35 years * Willingness to provide written informed consent
Exclusion criteria
* Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum, * Presence of communicable disease risk associated with xenotransplantation. * Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum. * Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device. * History of malignancy. * Pregnancy * In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture and expand mesenchymal stromal cells (MSC) | Day 1- cells are counted within 24 hours of bone marrow aspirate collection | Cell viability, proliferation profile, and expression characteristics will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization profile of MSC during and after expansion will be assessed | Examine the cell surface marker profile of MSC using standard flow cytometry | Cell surface expression profile will be obtained using Flow Cytometry. Additional characterization includes cell differentiation profile. |
Countries
United States
Outcome results
None listed