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Adult Stem Cell Response to Burn Injury

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ClinicalTrials.gov Identifier: NCT00609661
Recruitment Status : Withdrawn (Assay for stem cell analysis not available)
First Posted : February 7, 2008
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

January 24, 2008
February 7, 2008
October 8, 2012
February 2008
February 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00609661 on ClinicalTrials.gov Archive Site
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Adult Stem Cell Response to Burn Injury
Comparison of Burn Severity and Patient Outcomes to the Subsets of Mesenchymal Stem Cells Identified in the Blood of Burn Victims
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.).
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole Blood
Non-Probability Sample
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
  • Wound Healing
  • Burn
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
June 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00609661
2006H00286
No
Not Provided
Not Provided
Chandan K Sen, Ohio State University
Ohio State University
Not Provided
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
Ohio State University
October 2012