Adult Stem Cell Response to Burn Injury

This study has been withdrawn prior to enrollment.

(Assay for stem cell analysis not available)

Sponsor:

Information provided by (Responsible Party):

Chandan K Sen, Ohio State University

ClinicalTrials.gov Identifier:

NCT00609661

First received: January 24, 2008

Last updated: October 5, 2012

Last verified: October 2012

History of Changes

Purpose

This study is designed to determine the response of adult stems cells, also referred to as mesenchymal stem cells (MSCs), to tissue injury resulting from thermal burns. The study will consist of a one time collection of a patient's blood, about one teaspoon, on the third day following the initial burn. MSCs in the blood will then be quantitated and identified using according to unique proteins found on their cell surface using flow cytometry. The results of flow cytometry analysis will then be compared to the patients characteristics (age, sex, race, etc.), their past medical history (hx of diabetes, hypertension, heart disease, etc.) and to the patient outcome (length of hospital stay, mortality, etc.).

Condition
Wound Healing Burn

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Comparison of Burn Severity and Patient Outcomes to the Subsets of Mesenchymal Stem Cells Identified in the Blood of Burn Victims

Resource links provided by NLM:

MedlinePlus related topics: Burns

U.S. FDA Resources

Further study details as provided by Ohio State University:

Biospecimen Retention: Samples With DNA

Whole Blood

Enrollment:	0
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit following thermal burn.
2 Healthy volunteers

Detailed Description:

Traumatic and non-traumatic disease processes result in varying tissue injury that can culminate in organ failure and death. Current literature has demonstrated that adult stem cells (ASCs) are mobilized into peripheral circulation as a heterogeneous population of cells following tissue injury. The significance of this heterogeneity has not yet been defined. Other studies have shown ASCs augment tissue repair under appropriate conditions. This proposal will begin to elucidate the mechanism of ASC activation, mobilization and localization to sites of injury. This study will use flow cytometry to identify subsets of ASCs mobilized in response to tissue injury and compare this response to the patient's demographics, comorbidities, in hospital morbidities, and mortality. Patients with thermal burns will be used as a model of tissue injury given the quantity of tissue injured and the robust signal generated from this injury. ASCs are currently being investigated as adjuncts to tissue repair involving a host of tissues, including cardiac, neural, and renal. The identification of a specific subset of ASCs selectively mobilized in response to tissue injury would alter all studies involving ASCs in tissue repair and necessitate the identification and targeting of subsets selectively mobilized in response to injury to each particular tissue.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Any patient who is consented following presentation to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit within three days of a thermal burn

Criteria

Inclusion Criteria:

Any consentable patient presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit within three days of a thermal burn

Exclusion Criteria:

Prisoners
Pregnant patients and nonconsentable patients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609661

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:	Chandan K Sen, PhD	Ohio State University
Study Director:	Daniel P Zelinski, MD, PhD	Ohio State University
Study Director:	Sorabh Khandelwal, MD	Ohio State University

More Information

No publications provided

Responsible Party:	Chandan K Sen, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier:	NCT00609661 History of Changes
Other Study ID Numbers:	2006H00286
Study First Received:	January 24, 2008
Last Updated:	October 5, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Mesenchymal Stem Cells, Burn

Additional relevant MeSH terms:

Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013

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