Celacade
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Celacade was a non-drug, device-based treatment also known as Immune Modulation Therapy (IMT), developed by the Canadian-based biotherapeutics company Vasogen, Inc. for chronic heart failure and peripheral artery disease.[1][2] Blood was piped through the device, where it was exposed to heat, ultraviolet light, and ozone, in the hope that this oxidative stress would trigger an anti-inflammatory immunomodulation response.[3][4][5]
Despite some promising early results and one positive result in subgroup analysis, the technique usually did not produce the hoped-for clinically significant results.[3][5]
Research history
[edit]At the World Congress of Cardiology in September 2006 the Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) a phase III randomized, double-blind, placebo-controlled clinical trial involving some 2408 patients in 7 countries with left ventricular ejection fraction of 30% or less, reported that only one subgroup – patients with a previous cardiovascular event – benefited from the treatment.[3] These people were 39% less likely to die or be hospitalized due to a heart attack or stroke and tended to have improved quality of life.[6][3]
Marketing approval
[edit]Vasogen in collaboration with Grupo Ferrer Internacional has regulatory approval to market Celacade as a medical device for the treatment of chronic heart failure in the European Union and Latin America.[7]
References
[edit]- ^ Visioli F (September 2001). "VasoCare. Vasogen". Curr Opin Investig Drugs. 2 (9): 1247–9. PMID 11717811.
- ^ "Immune modulation therapy-peripheral vascular disease--Vasogen (VasoCare)". Drugs in R&D. 3 (5): 358–60. 2002. doi:10.2165/00126839-200203050-00013. PMID 12455159. S2CID 195340233.
- ^ a b c d Kumar, Soumitra (2018-03-31). The Protocol Book for Intensive Care. JP Medical Ltd. pp. 165–166. ISBN 978-93-5270-305-0.
- ^ Bulmer J, Bolton AE, Pockley AG (1997). "Effect of combined heat, ozonation and ultraviolet irradiation (VasoCare) on heat shock protein expression by peripheral blood leukocyte populations". J. Biol. Regul. Homeost. Agents. 11 (3): 104–10. PMID 9498159.
- ^ a b Tousoulis, Dimitris; Stefanadis, Christodoulos (2013-07-29). Biomarkers in Cardiovascular Diseases. CRC Press. p. 380. ISBN 978-1-4665-8714-4.
- ^ Torre-Amione G, Bourge RC, Colucci WS, et al. (April 2007). "A study to assess the effects of a broad-spectrum immune modulatory therapy on mortality and morbidity in patients with chronic heart failure: the ACCLAIM trial rationale and design". Can J Cardiol. 23 (5): 369–76. doi:10.1016/s0828-282x(07)70770-5. PMC 2649187. PMID 17440642.
- ^ "Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade in the European Union". Vasogen Inc. April 18, 2007.