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University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01463475
First received: September 30, 2011
Last updated: October 28, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Graft Versus Host Disease (GVHD)
Acute Myocardial Infarction (AMI)
 Procedure: Bone marrow aspirate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Culture and expand mesenchymal stromal cells (MSC) [ Time Frame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection ] [ Designated as safety issue: No ]
    Cell viability, proliferation profile, and expression characteristics will be evaluated.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Cell surface expression profile will be obtained using Flow Cytometry. Additional characterization includes cell differentiation profile.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bone marrow aspirate
    A single bone marrow aspirate procedure is planned.
    Other Name: bone marrow-derived MSC
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463475

Locations
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)
Investigators
Principal Investigator: Peiman Hematti, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01463475     History of Changes
Other Study ID Numbers: H-2010-0104, HHSN268201000010C
Study First Received: September 30, 2011
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013