University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

December 2, 2014 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • bone marrow-derived MSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1- cells are counted within 24 hours of bone marrow aspirate collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Examine the cell surface marker profile of MSC using standard flow cytometry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Peiman Hematti, MD, University of Wisconsin, Madison
  • Study Director: John M Centanni, MS, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 28, 2011

First Posted (ESTIMATE)

November 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2010-0104
  • HHSN268201000010C (OTHER_GRANT: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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