Open-label uncontrolled phase II study of pharmacokinetics, safety and biomarkers of effectiveness of NeuroSTAT (ciclosporin) in patients with severe traumatic brain injury
Traumatic Brain Injury
Enrolment: 16 · Results not recorded
Drug · Cyclophilin A modulator
2 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.
Traumatic Brain Injury
Enrolment: 16 · Results not recorded
Traumatic Brain Injury
Enrolment: 26 · Results not recorded
Liver Transplantation
Enrolment: 92 · Results not recorded
Hepatitis C
Enrolment: 39 · Results not recorded
Heart Transplantation · Acute Renal Failure
Enrolment: 30 · Results not recorded
Dry Eye · Contact Lens Complication
Enrolment: 44 · Results not recorded
Atopic Conjunctivitis
Enrolment: 176 · Results not recorded
Acute Myocardial Infarction
Enrolment: 410 · Results not recorded
Transplantation of Kidney
Enrolment: 48 · Results not recorded
Kidney Transplantation
Enrolment: 383 · Results not recorded
Dry Eye Syndromes
Enrolment: 7 · Results not recorded
Idiopathic Membranous Nephropathy · Proteinuria
Enrolment: 180 · Results not recorded
Renal Artery Stenosis
Enrolment: 5 · Results not recorded
Epiphora
Enrolment: 0 · Results not recorded
Thrombocytopenia · Hepatitis B · Cirrhosis
Enrolment: 15 · Results not recorded
Kidney Transplantation
Enrolment: 22 · Results not recorded
AKI · Therapeutic Drug Monitoring
Enrolment: 1200 · Results not recorded
7 studies reported at therapy level; 17 evidence entries itemised.
Model: Full-thickness thermal injury covering 30% of total body surface area, with associated acute lung injury
Cyclosporine-A produced dose-dependent reductions in circulating mitochondrial DNA and inflammatory mediators (p less than .05), mitigated the severity of lung injury and attenuated oxidative stress and release of cytochrome c and mitochondrial DNA in lung tissue.
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Model: Lipopolysaccharide-induced acute lung injury (intraperitoneal LPS 10 mg/kg)
Both doses of cyclosporine-A reduced the lipopolysaccharide-induced rise in lung wet to dry ratio, myeloperoxidase activity, lavage total cells and neutrophils. Only the 25 mg/kg dose significantly improved the histological lung injury score and reduced lavage total protein. Plasma mitochondrial DN…
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Model: Controlled cortical impact, 4 mm craniotomy over the left parietal bone, impact at 5.25 m/s velocity with 1.5 mm tissue deformation; sham animals received anaesthesia and incision without impact
Blood brain barrier permeability peaked at day 1 (411% increase in ipsilateral cortex Evans blue) and closed spontaneously by 7 to 10 days. Cyclosporin A attenuated microvessel MMP-9 responses and returned barrier permeability to sham levels by 5 days post-injury, whereas vehicle mice remained 135%…
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Model: Three parallel models: parasagittal fluid percussion injury, controlled cortical impact and penetrating ballistic-like brain injury
Cyclosporin A at 10 mg/kg gave histological protection in the least severe model (fluid percussion injury), but 20 mg/kg worsened working memory in that model and impaired Morris water maze performance after controlled cortical impact, with increased mortality after penetrating ballistic-like brain…
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Model: Penetrating ballistic-like brain injury
Cyclosporin A at 2.5 mg/kg reduced the 2 h post-injury serum glial fibrillary acidic protein elevation 22.4-fold relative to injury plus vehicle (p<0.05) and improved neurological function at 1 day after injury.
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Model: Acute pulmonary embolism induced by intravenous injection of microspheres, causing right ventricular injury and dysfunction
Cyclophilin A and CD147 rose synchronously in right ventricular tissue after embolism, peaking at 24 h. Cyclosporine A reduced cyclophilin A levels and anti-CD147 abrogated the CD147 rise. Treatment with cyclosporine A, anti-CD147 or both attenuated the increases in right ventricular systolic press…
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Model: Pressure-controlled haemorrhagic shock (mean arterial pressure 38 (1) mm Hg for 90 min) followed by transfusion of shed blood
Both cyclosporine A doses significantly prolonged survival, 50 mg/kg lowered plasma interleukin-6 and thiobarbituric acid-reactive substances, Akt, GSK-3beta and Bad phosphorylation increased, and mitochondrial ultrastructural change was less marked, although liver histological injury did not diffe…
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