University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Study Overview
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Brief Summary
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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
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Cell banks will be manufactured and cellular products used for future translational or clinical research.

Official Title
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University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Conditions
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Graft Versus Host Disease (GVHD), Acute Myocardial Infarction (AMI)

Intervention / Treatment
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* Procedure: Bone marrow aspirate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bone Marrow Aspirate<br>A qualified enrolled donor will have an aspirate bone marrow draw. | Procedure: Bone marrow aspirate<br>* A single bone marrow aspirate procedure is planned.<br>* Other names: bone marrow-derived MSC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture and expand mesenchymal stromal cells (MSC) | Cell viability, proliferation profile, and expression characteristics will be evaluated. | Day 1- cells are counted within 24 hours of bone marrow aspirate collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization profile of MSC during and after expansion will be assessed | Cell surface expression profile will be obtained using Flow Cytometry. Additional characterization includes cell differentiation profile. | Examine the cell surface marker profile of MSC using standard flow cytometry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSC, Allogeneic, Bone marrow cells, Healthy subject donors, Collection of MSC from bone marrow aspirate, Bronchiolitis obliterans syndrome (BOS)