IVIG in Acute Ischemic Stroke: A Pilot Study "IVIG/AIS"

Withdrawn

Phase 1 Results N/A

References

Publications

  • D'Ambrosio AL, Pinsky DJ, Connolly ES. The role of the complement cascade in ischemia/reperfusion injury: implications for neuroprotection. Mol Med. 2001 Jun;7(6):367-82. Review. PubMed Pubmed ID:11474130
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  • Van Beek J, Bernaudin M, Petit E, Gasque P, Nouvelot A, MacKenzie ET, Fontaine M. Expression of receptors for complement anaphylatoxins C3a and C5a following permanent focal cerebral ischemia in the mouse. Exp Neurol. 2000 Jan;161(1):373-82. PubMed Pubmed ID:10683302
  • Lindsberg PJ, Ohman J, Lehto T, Karjalainen-Lindsberg ML, Paetau A, Wuorimaa T, Carpén O, Kaste M, Meri S. Complement activation in the central nervous system following blood-brain barrier damage in man. Ann Neurol. 1996 Oct;40(4):587-96. PubMed Pubmed ID:8871578
  • Nishino H, Czurkó A, Fukuda A, Hashitani T, Hida H, Karadi Z, Lénárd L. Pathophysiological process after transient ischemia of the middle cerebral artery in the rat. Brain Res Bull. 1994;35(1):51-6. PubMed Pubmed ID:7953757
  • Figueroa E, Gordon LE, Feldhoff PW, Lassiter HA. The administration of cobra venom factor reduces post-ischemic cerebral injury in adult and neonatal rats. Neurosci Lett. 2005 May 20-27;380(1-2):48-53. Epub 2005 Feb 2. PubMed Pubmed ID:15854749
  • Arumugam TV, Tang SC, Lathia JD, Cheng A, Mughal MR, Chigurupati S, Magnus T, Chan SL, Jo DG, Ouyang X, Fairlie DP, Granger DN, Vortmeyer A, Basta M, Mattson MP. Intravenous immunoglobulin (IVIG) protects the brain against experimental stroke by preventing complement-mediated neuronal cell death. Proc Natl Acad Sci U S A. 2007 Aug 28;104(35):14104-9. Epub 2007 Aug 21. PubMed Pubmed ID:17715065
  • Széplaki G, Szegedi R, Hirschberg K, Gombos T, Varga L, Karádi I, Entz L, Széplaki Z, Garred P, Prohászka Z, Füst G. Strong complement activation after acute ischemic stroke is associated with unfavorable outcomes. Atherosclerosis. 2009 May;204(1):315-20. Epub 2008 Aug 14. PubMed Pubmed ID:18804761
  • De Simoni MG, Rossi E, Storini C, Pizzimenti S, Echart C, Bergamaschini L. The powerful neuroprotective action of C1-inhibitor on brain ischemia-reperfusion injury does not require C1q. Am J Pathol. 2004 May;164(5):1857-63. PubMed Pubmed ID:15111332
  • De Simoni MG, Storini C, Barba M, Catapano L, Arabia AM, Rossi E, Bergamaschini L. Neuroprotection by complement (C1) inhibitor in mouse transient brain ischemia. J Cereb Blood Flow Metab. 2003 Feb;23(2):232-9. PubMed Pubmed ID:12571454
  • Akita N, Nakase H, Kaido T, Kanemoto Y, Sakaki T. Protective effect of C1 esterase inhibitor on reperfusion injury in the rat middle cerebral artery occlusion model. Neurosurgery. 2003 Feb;52(2):395-400; discussion 400-1. PubMed Pubmed ID:12535370
  • Akita N, Nakase H, Kanemoto Y, Kaido T, Nishioka T, Sakaki T. [The effect of C 1 esterase inhibitor on ischemia: reperfusion injury in the rat brain]. No To Shinkei. 2001 Jul;53(7):641-4. Japanese. PubMed Pubmed ID:11517488
  • Basta M, Fries LF, Frank MM. High doses of intravenous Ig inhibit in vitro uptake of C4 fragments onto sensitized erythrocytes. Blood. 1991 Jan 15;77(2):376-80. PubMed Pubmed ID:1985703
  • Basta M, Langlois PF, Marques M, Frank MM, Fries LF. High-dose intravenous immunoglobulin modifies complement-mediated in vivo clearance. Blood. 1989 Jul;74(1):326-33. PubMed Pubmed ID:2752117
  • Basta M, Kirshbom P, Frank MM, Fries LF. Mechanism of therapeutic effect of high-dose intravenous immunoglobulin. Attenuation of acute, complement-dependent immune damage in a guinea pig model. J Clin Invest. 1989 Dec;84(6):1974-81. PubMed Pubmed ID:2687331
  • Basta M. Modulation of complement-mediated immune damage by intravenous immune globulin. Clin Exp Immunol. 1996 May;104 Suppl 1:21-5. PubMed Pubmed ID:8625538
  • Basta M, Van Goor F, Luccioli S, Billings EM, Vortmeyer AO, Baranyi L, Szebeni J, Alving CR, Carroll MC, Berkower I, Stojilkovic SS, Metcalfe DD. F(ab)'2-mediated neutralization of C3a and C5a anaphylatoxins: a novel effector function of immunoglobulins. Nat Med. 2003 Apr;9(4):431-8. Epub 2003 Mar 3. PubMed Pubmed ID:12612546
  • Basta M. Ambivalent effect of immunoglobulins on the complement system: activation versus inhibition. Mol Immunol. 2008 Oct;45(16):4073-9. Epub 2008 Aug 15. Review. PubMed Pubmed ID:18706699
  • Spycher M, Matozan K, Minnig K, Zehnder R, Miescher S, Hoefferer L, Rieben R. In vitro comparison of the complement-scavenging capacity of different intravenous immunoglobulin preparations. Vox Sang. 2009 Nov;97(4):348-54. Epub 2009 Jul 27. PubMed Pubmed ID:19656348
  • Al-Buhairi AR, Jan MM. Recombinant tissue plasminogen activator for acute ischemic stroke. Saudi Med J. 2002 Jan;23(1):13-9. Review. PubMed Pubmed ID:11938357
  • Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. JAMA. 1999 Dec 1;282(21):2019-26. PubMed Pubmed ID:10591384
  • Bennett WR, Yawn DH, Migliore PJ, Young JB, Pratt CM, Raizner AE, Roberts R, Bolli R. Activation of the complement system by recombinant tissue plasminogen activator. J Am Coll Cardiol. 1987 Sep;10(3):627-32. PubMed Pubmed ID:3114350
  • Széplaki G, Varga L, Laki J, Dósa E, Madsen HO, Prohászka Z, Szabó A, Acsády G, Selmeci L, Garred P, Füst G, Entz L. Elevated complement C3 is associated with early restenosis after eversion carotid endarterectomy. Thromb Haemost. 2006 Oct;96(4):529-34. PubMed Pubmed ID:17003933
  • Darabi K, Abdel-Wahab O, Dzik WH. Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature. Transfusion. 2006 May;46(5):741-53. Review. PubMed Pubmed ID:16686841
  • Ahsan N, Palmer BF, Wheeler D, Greenlee RG Jr, Toto RD. Intravenous immunoglobulin-induced osmotic nephrosis. Arch Intern Med. 1994 Sep 12;154(17):1985-7. PubMed Pubmed ID:8074604
  • Bednarík J, Kadanka Z. [Adverse effects of administration of intravenous human immunoglobulins]. Cas Lek Cesk. 1999 Nov 1;138(21):647-9. Review. Czech. PubMed Pubmed ID:10746020
  • Orbach H, Katz U, Sherer Y, Shoenfeld Y. Intravenous immunoglobulin: adverse effects and safe administration. Clin Rev Allergy Immunol. 2005 Dec;29(3):173-84. Review. PubMed Pubmed ID:16391392
  • Al-Wahadneh AM, Khriesat IA, Kuda EH. Adverse reactions of intravenous immunoglobulin. Saudi Med J. 2000 Oct;21(10):953-6. PubMed Pubmed ID:11369961
  • Katz U, Shoenfeld Y. Review: intravenous immunoglobulin therapy and thromboembolic complications. Lupus. 2005;14(10):802-8. Review. PubMed Pubmed ID:16302674
  • Reinhart WH, Berchtold PE. Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet. 1992 Mar 14;339(8794):662-4. PubMed Pubmed ID:1347348
  • Fisher M. Characterizing the target of acute stroke therapy. Stroke. 1997 Apr;28(4):866-72. Review. Pubmed ID:9099209
  • Lansberg MG, O'Brien MW, Tong DC, Moseley ME, Albers GW. Evolution of cerebral infarct volume assessed by diffusion-weighted magnetic resonance imaging. Arch Neurol. 2001 Apr;58(4):613-7. PubMed Pubmed ID:11295992

Sources for Trial Information