Skip to main content
. 2021 Jun 23;12:678744. doi: 10.3389/fimmu.2021.678744

Table 2.

Randomized controlled trials targeting immune cells in human ischemic stroke.

Treatment Mechanism Author Year Study place Sample Size Intervention Outcome Reference
Time window, duration Drug dose Administration route mRS/ΔSSS/mBI at day 90 Mortality rate Infarct volume at day 5/NIHSS score at 1 week Adverse event
Anti-ICAM-1 (Enlimomab) Inhibiting leukocytes infiltration Enlimomab Acute Stroke Trial Investigators 2001 USA Europe Enlimomab (n=317) placebo (n=308) Within 6 hours after onset; 5 days LB: 160mg; MB: 40mg Intravenously worse Higher -* More infections and fever (214)
Anti-Mac-1(UK-279,276) Inhibiting leukocytes infiltration Krams 2003 UK 966 patients randomly treated Once within 6 hours after onset 1 of 15 doses (dose range, 10 to 120 mg) Intravenously Not significant Similar More headache (215)
Anti-α4 integrin (natalizumab) Inhibiting lymphocyte infiltration Elkins 2017 USA Europe Natalizumab (n=79) Placebo (n=82) Once up to 9 h after onset 300 mg Intravenously More good outcome Similar Similar (225)
Anti-α4 integrin (natalizumab) Inhibiting lymphocyte infiltration Elkind 2020 USA Europe 300mg Natalizumab (n=91) 600mg Natalizumab (n=92) Placebo(n=94) ≤9 or >9 to ≤24 hours 300 or 600 mg Intravenously Similar Similar Similar (226)
S1PR agonist (fingolimod) Inhibiting lymphocyte infiltration Fu 2014 China Fingolimod (n=11) Control (n=11) Within 72 hours after onset; 3 days 0.5mg Orally More good outcome No Less No serious event (227)
S1PR agonist (fingolimod) Inhibiting lymphocyte infiltration Zhu 2015 China Fingolimod (n=25) Control (n=22) Within 4.5 hours after onset; 3 days 0.5mg Orally More good outcome Less No serious event (228)
S1PR agonist (fingolimod) Inhibiting lymphocyte infiltration Tian 2018 China Fingolimod (n=23) Control (n=23) 4.5-6 hours after onset; 3 days 0.5mg Orally More good outcome No death Less No serious event (226)
Resveratrol Regulating lymphocyte subsets Chen 2016 China Resveratrol (n=154) Placebo (n=158) Within 4 hours after onset 2.5 mg/kg Intravenously Only 24 hours NIHSS score is evaluated, Resveratrol reduce NIHSS score at 24 hours (229)
Atorvastatin Regulating lymphocyte subsets Muscari 2011 Italy Atorvastatin (n=31) Placebo (n=31) Within 24 hours after onset; 7 days 80mg Orally More good outcome Similar Similar Similar (230)
Rosuvastatin Inhibiting microglia activation Heo 2016 Korea Rosuvastatin (n=155) Placebo (n=159) Within 66 hours after onset; 14 days 20 mg Orally Similar Similar Similar (231)
Minocycline Inhibiting immune cells activation Westphal 2007 Israel Minocycline (n=74) Placebo (n=77) 6-24 hours after stroke onset; 5 days 200 mg Orally More good outcome Similar Similar (232)
IL-1 receptor antagonist (rhIL-1ra) Inhibiting IL-1 Emsley 2005 UK rhIL-1ra (n=17) Placebo (n=17) Within 6 hours after onset; 3 days LB: 100mg; MB: 2mg/kg/h Intravenously More good outcome in cortical infarcts patients Similar Less in cortical infarcts patients Similar (233)
IL-1 Receptor Antagonist (IL-1Ra) Inhibiting IL-1 Smith 2018 UK IL-1Ra (n=39) Placebo (n=41) Within 5 hours after onset; 3 days 100 mg twice daily subcutaneously Similar Similar Similar Similar (234)

*not mentioned in the study.

AIS, acute ischemic stroke; mRS, modified ed Rankin Scale; ΔSSS, the Scandinavian Stroke Scale; mBI, modified Barthel Index; NIHSS, the National Institute of Health Stroke Scale; ICAM-1, intercellular adhesion molecule-1; USA, The United States of America; LB, loading bonus; MB: maintenance bolus; RCT, Randomized Controlled Trial; MAC-1, macrophage-1 antigen; UK, The United Kingdom; S1PR, sphingosine 1-phosphate receptor; rhIL-1ra, recombinant interleukin-1 receptor antagonist.