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Completed

NCT Number: NCT01463475

University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

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.

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Key information

Conditions

Graft Versus Host Disease (GVHD) Acute Myocardial Infarction (AMI) Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Marrow Aspirate

Procedure

A single bone marrow aspirate procedure is planned.

Other names: bone marrow-derived MSC

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2011
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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