- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00609661
Adult Stem Cell Response to Burn Injury
5. oktober 2012 opdateret af: 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.).
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
2
Sunde frivillige
|
1
Patients presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit following thermal burn.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Chandan K Sen, PhD, Ohio State University
- Studieleder: Daniel P Zelinski, MD, PhD, Ohio State University
- Studieleder: Sorabh Khandelwal, MD, Ohio State University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2008
Primær færdiggørelse (Forventet)
1. februar 2010
Studieafslutning (Forventet)
1. juni 2010
Datoer for studieregistrering
Først indsendt
24. januar 2008
Først indsendt, der opfyldte QC-kriterier
6. februar 2008
Først opslået (Skøn)
7. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. oktober 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2012
Sidst verificeret
1. oktober 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006H00286
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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