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University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

NCT ID: NCT01463475

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Bone Marrow Aspirate

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

Group Type OTHER

Bone marrow aspirate

Intervention Type PROCEDURE

A single bone marrow aspirate procedure is planned.

Interventions

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Bone marrow aspirate

A single bone marrow aspirate procedure is planned.

Intervention Type PROCEDURE

Other Intervention Names

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bone marrow-derived MSC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peiman Hematti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

John M Centanni, MS

Role: STUDY_DIRECTOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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HHSN268201000010C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-2010-0104

Identifier Type: -

Identifier Source: org_study_id