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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014