Source:http://linkedlifedata.com/resource/pubmed/id/21401865
Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
4
|
| pubmed:dateCreated |
2011-3-30
|
| pubmed:databankReference | |
| pubmed:abstractText |
The selectin antagonist known as recombinant P-selectin glycoprotein ligand IgG (rPSGL-Ig) blocks leukocyte adhesion and protects against transplantation ischemia reperfusion injury (IRI) in animal models. This randomized (1:1) single-center double-blind 47-patient phase 2 study with 6-month follow-up assessed rPSGL-Ig's safety and impact on early graft function at 1 mg/kg systemic dose with pretransplant allograft ex vivo treatment in deceased-donor liver transplant recipients. Safety was assessed in all patients, whereas efficacy was assessed in a prospectively defined per-protocol patient set (PP) by peak serum transaminase (TA) and bilirubin values, and normalization thereof. In PP patients, the incidence of poor early graft function (defined as peak TA >2500 U/L or bilirubin >10 mg/dL), average peak liver enzymes and bilirubin, normalization thereof and duration of primary and total hospitalization trended consistently lower in the rPSGL-Ig group compared to placebo. In patients with donor risk index above study-average, normalization of aspartate aminotransferase was significantly improved in the rPSGL-Ig group (p < 0.03). rPSGL-Ig treatment blunted postreperfusion induction versus placebo of IRI biomarker IP-10 (p < 0.1) and augmented cytoprotective IL-10 (p < 0.05). This is the first clinical trial of an adhesion molecule antagonist to demonstrate a beneficial effect on liver transplantation IRI and supported by therapeutic modulation of two hepatic IRI biomarkers.
|
| pubmed:grant | |
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Apr
|
| pubmed:issn |
1600-6143
|
| pubmed:author |
pubmed-author:BusuttilR WRW,
pubmed-author:CheadleCC,
pubmed-author:EhrlichEE,
pubmed-author:GjertsonD WDW,
pubmed-author:HemmerichSS,
pubmed-author:KatzEE,
pubmed-author:Kupiec-WeglinskiJ WJW,
pubmed-author:LipshutzG SGS,
pubmed-author:PonthieuxSS,
pubmed-author:RabeUU,
pubmed-author:SquiersE CEC,
pubmed-author:WatkinsTT
|
| pubmed:copyrightInfo |
©2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.
|
| pubmed:issnType |
Electronic
|
| pubmed:volume |
11
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
786-97
|
| pubmed:meshHeading |
pubmed-meshheading:21401865-Adult,
pubmed-meshheading:21401865-Aged,
pubmed-meshheading:21401865-Double-Blind Method,
pubmed-meshheading:21401865-Female,
pubmed-meshheading:21401865-Graft Rejection,
pubmed-meshheading:21401865-Humans,
pubmed-meshheading:21401865-Interleukin-10,
pubmed-meshheading:21401865-Liver Function Tests,
pubmed-meshheading:21401865-Liver Transplantation,
pubmed-meshheading:21401865-Male,
pubmed-meshheading:21401865-Membrane Glycoproteins,
pubmed-meshheading:21401865-Middle Aged,
pubmed-meshheading:21401865-Recombinant Proteins,
pubmed-meshheading:21401865-Reperfusion Injury,
pubmed-meshheading:21401865-Transplantation, Homologous
|
| pubmed:year |
2011
|
| pubmed:articleTitle |
rPSGL-Ig for improvement of early liver allograft function: a double-blind, placebo-controlled, single-center phase II study.
|
| pubmed:affiliation |
Dumont UCLA Transplant Center, Los Angeles, CA, USA. magnin@ccf.org
|
| pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase II,
Research Support, N.I.H., Extramural
|