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University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

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ClinicalTrials.gov Identifier: NCT01463475
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : December 4, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Graft Versus Host Disease (GVHD) Acute Myocardial Infarction (AMI) Procedure: Bone marrow aspirate

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
Study Start Date : September 2011
Primary Completion Date : December 2013
Study Completion Date : December 2013

Arm Intervention/treatment
Bone Marrow Aspirate
A qualified enrolled donor will have an aspirate bone marrow draw.
Procedure: Bone marrow aspirate
A single bone marrow aspirate procedure is planned.
Other Name: bone marrow-derived MSC

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Characterization profile of MSC during and after expansion will be assessed [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463475

United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Peiman Hematti, MD University of Wisconsin, Madison
Study Director: John M Centanni, MS University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01463475     History of Changes
Other Study ID Numbers: H-2010-0104
HHSN268201000010C ( Other Grant/Funding Number: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE )
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by University of Wisconsin, Madison:
Bone marrow cells
Healthy subject donors
Collection of MSC from bone marrow aspirate
Bronchiolitis obliterans syndrome (BOS)

Additional relevant MeSH terms:
Myocardial Infarction
Graft vs Host Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases