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Recent approaches to disrupting or influencing this inflammatory cascade have involved inflammatory cytokines, such as tumour necrosis factor (TNF-α) and interleukin 10, and more recently cellular adhesion molecules.
The diverse adhesion molecule group is responsible for cell “rolling”, “sticking”, and leucocyte migration through vascular endothelium at inflammatory sites.
Double blind, placebo controlled trial of the remission inducing and steroid sparing properties of an ICAM-1 antisense oligodeoxynucleotide, alicaforsen (ISIS 2302), in active steroid dependent Crohn's disease Background and aims: To evaluate the safety and efficacy of the intercellular adhesion molecule 1 (ICAM-1) antisense phosphorothioate oligonucleotide alicaforsen (ISIS 2302) in Crohn's disease.
Methods: Active (Crohn's disease activity index (CDAI) 200–350), steroid dependent (prednisone 10–40 mg) Crohn's patients were randomised into three treatment groups: placebo versus ISIS 2302 (2 mg/kg intravenously three times a week) for two or four weeks.
Patients in remission at month 6 were followed for an additional six months.
Investigators were blinded for 12 months and Isis personnel for six months after data had been collected and the database locked.
The maximum permitted dosage was 200 mg; a few patients weighing Study plan.
Anti-ISIS 2302 antibody levels were measured by ELISA (Covance, Vienna, Virginia, USA) using goat antihuman Ig G and Ig M peroxidase conjugated second antibodies (Cappel) for detection, and mouse monoclonal Ig G anti-ISIS 2302 antibody (Harlan Bioproducts for Science, Indianapolis, Indiana, USA) as a positive control.
Positive results were confirmed by adding blocking levels of free ISIS 2302.
As phosphorothioate oligonucleotides transiently prolong the a PTT, post infusion a PTT results could have unblinded the study.
Investigators and ISIS personnel remained blinded to a PTT results throughout the trial.