University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

University of Wisconsin, Madison3 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

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

Interventions

Bone marrow aspiratePROCEDURE

A single bone marrow aspirate procedure is planned.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Wisconsin-Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Culture and expand mesenchymal stromal cells (MSC)

Cell viability, proliferation profile, and expression characteristics will be evaluated.

Time frame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection

Secondary Outcomes

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.

Time frame: Examine the cell surface marker profile of MSC using standard flow cytometry

Data from ClinicalTrials.gov

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