University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Culture and expand mesenchymal stromal cells (MSC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Culture and expand mesenchymal stromal cells (MSC)
Time Frame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection
Cell viability, proliferation profile, and expression characteristics will be evaluated.
Secondary Outcomes
- Characterization profile of MSC during and after expansion will be assessed(Examine the cell surface marker profile of MSC using standard flow cytometry)