- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609661
Adult Stem Cell Response to Burn Injury
October 5, 2012 updated by: Chandan K Sen, Ohio State University
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.).
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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2
Healthy volunteers
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1
Patients presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit following thermal burn.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Anticipated)
February 1, 2010
Study Completion (Anticipated)
June 1, 2010
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
October 8, 2012
Last Update Submitted That Met QC Criteria
October 5, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006H00286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.