University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Not Applicable

Completed

• Conditions: Graft Versus Host Disease (GVHD); Acute Myocardial Infarction (AMI)
• Interventions: Procedure: Bone marrow aspirate

• Registration Number: NCT01463475
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-11-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone Marrow Aspirate	Bone marrow aspirate	A qualified enrolled donor will have an aspirate bone marrow draw.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States