Celacade is a non-pharmacological treatment also known as Immune Modulation Therapy (IMT), developed by the Canadian based biotherapeutics company Vasogen, for treatment of chronic heart failure and peripheral artery disease. ^[1][2]

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 patients with a previous cardiovascular event receiving celacade where 39% less likely to die or be hospitalized due to a heart attack or stroke and tended to have improved quality of life. ^[3] Celacade is believed to inhibit inflammation, platelet aggregation and progression of arterial lesions by a mechanism independent of cholesterol lowering. ^[4]

Celcade is a device-based outpatient procedure involving ex vivo exposure of 10ml autologous blood to heat, ultraviolet irradiation, controlled oxidative ozone therapy and subsequent intramuscular administration at monthly intervals. ^[5]

The results of ACCLAIM support the hypothesis that immune dysfunction plays a role in the pathogenesis of atherosclerosis ^[6] and Immune Modulation therapy has a broad-spectrum positive effect on a number of immune mediators, including regulation and enhancement of cytokines and the vascular dilator nitric oxide. These cell signaling molecules regulate inflammation and facilitate the healing process. ^{[7][8][9][10]}

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.^[11]

In the United States the Food and Drug Administration (FDA) has recommended that Vasogen conduct a further confirmatory study to support a pre-market approval filing. ^[12]

[edit] References

1. ^ Visioli F (September 2001). "VasoCare. Vasogen". Curr Opin Investig Drugs 2 (9): 1247–9. PMID 11717811. 
2. ^ &Na;, (2002). "Immune modulation therapy-peripheral vascular disease--Vasogen (VasoCare)". Drugs R D 3 (5): 358–60. doi:10.2165/00126839-200203050-00013. PMID 12455159. 
3. ^ 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. PMID 17440642. 
4. ^ Babaei S, Stewart DJ, Picard P, Monge JC (May 2002). "Effects of VasoCare therapy on the initiation and progression of atherosclerosis". Atherosclerosis 162 (1): 45–53. doi:10.1016/S0021-9150(01)00680-3. PMID 11947896. http://linkinghub.elsevier.com/retrieve/pii/S0021915001006803. 
5. ^ 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. 
6. ^ Mari D, Di Berardino F, Cugno M (December 2002). "Chronic heart failure and the immune system". Clin Rev Allergy Immunol 23 (3): 325–40. doi:10.1385/CRIAI:23:3:325. PMID 12402415. 
7. ^ "Method of increasing the concentration of nitric oxide in human blood". United States Patent # 5,834,030. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,834,030.PN.&OS=PN/5,834,030&RS=PN/5,834,030. 
8. ^ "Method of inhibiting the aggregation of blood platelets and stimulating the immune systems of a human". United States patent # 5,591,457. 1997. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,591,457.PN.&OS=PN/5,591,457&RS=PN/5,591,457. 
9. ^ Torre-Amione G, Sestier F, Radovancevic B, Young J (June 2005). "Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression". Am. J. Cardiol. 95 (11A): 30C–37C; discussion 38C–40C. doi:10.1016/j.amjcard.2005.03.010. PMID 15925562. 
10. ^ Torre-Amione G, Sestier F, Radovancevic B, Young J (September 2004). "Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: results of a randomized, controlled, phase II trial". J. Am. Coll. Cardiol. 44 (6): 1181–6. doi:10.1016/j.jacc.2004.06.047. PMID 15364317. 
11. ^ "Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade in the European Union". Vasogen Inc April 18, 2007. http://www.vasogen.com/sec/pr_1176892968. 
12. ^ "Vasogen Reports on Outcome of FDA Meeting". Vasogen press release - June 27, 2007. http://www.vasogen.com/sec/pr_1182920278. 

[edit] External links

• Celacade page on the Vasogen website

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