University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Acute Myocardial Infarction (AMI) Clinical Trial

Official title:

University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463475
• Other study ID #: H-2010-0104
• Secondary ID: HHSN268201000010
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: December 2, 2014
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Bone marrow aspirate
A single bone marrow aspirate procedure is planned.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes