University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

NCT01463475 | Completed

• 2 other identifiers: H-2010-0104HHSN268201000010C
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease (GVHD); Acute Myocardial Infarction (AMI)

Keywords

MSC; Allogeneic; Bone marrow cells; Healthy subject donors; Collection of MSC from bone marrow aspirate; Bronchiolitis obliterans syndrome (BOS)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Characterization profile of MSC during and after expansion will be assessed

  Examine the cell surface marker profile of MSC using standard flow cytometry

Study Arms (1)

Bone Marrow Aspirate

OTHER

A qualified enrolled donor will have an aspirate bone marrow draw.

Procedure: Bone marrow aspirate

Interventions

Bone marrow aspirate PROCEDURE

A single bone marrow aspirate procedure is planned.

Also known as: bone marrow-derived MSC

Bone Marrow Aspirate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 35 years
• Willingness to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Peiman Hematti, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• John M Centanni, MS

  University of Wisconsin, Madison

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: November 2, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)