University of Wisconsin hMSC Cell Bank: Bone Marrow Donor... | NCT01463475

Studies
University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

NCT01463475

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

3Actual

Phase

Not Applicable

Conditions

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

Interventions

Bone marrow aspirate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HHSN268201000010C	Other Grant/Funding Number	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 30, 2011

First Submission Date that Met QC Criteria

Oct 28, 2011

First Posted Date

Nov 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone Marrow Aspirate	Other	A qualified enrolled donor will have an aspirate bone marrow draw.	Procedure: Bone marrow aspirate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow aspirate	Procedure	A single bone marrow aspirate procedure is planned.	Bone Marrow Aspirate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Characterization profile of MSC during and after expansion will be assessed	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peiman Hematti, MD	University of Wisconsin, Madison	Principal Investigator
John M Centanni, MS	University of Wisconsin, Madison	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin-Madison		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis

Browse Leaves

Not provided

Browse Branches

Not provided