Celacade

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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 FDA has recommended that Vasogen conduct a further confirmatory study to support a pre-market approval filing. [12]

[edit] References

  1. ^ VasoCare. Vasogen.. Current Opinion Investigational Drugs 2001.
  2. ^ Immune modulation therapy-peripheral vascular disease--Vasogen (VasoCare).. Drugs in Reasearch and Development 2002..
  3. ^ 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. Canadian Journal of Cardiology 2007.
  4. ^ Effects of VasoCare therapy on the initiation and progression of atherosclerosis. Journal of Atherosclerosis 2002.
  5. ^ Effect of combined heat, ozonation and ultraviolet irradiation (VasoCare) on heat shock protein expression by peripheral blood leukocyte populations.. Biological Regulators & Homeostatic Agents 1997.
  6. ^ Chronic Heart Failure and the Immune System.. Clinical Reviews of Allergy Immunology 2002..
  7. ^ Method of increasing the concentration of nitric oxide in human blood. United States Patent # 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.
  9. ^ Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression.. American Journal Cardiology 2005.
  10. ^ Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: results of a randomized, controlled, phase II trial. Journal of American College Cardiology 2004.
  11. ^ Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade in the European Union. Vasogen Inc April 18, 2007.
  12. ^ Vasogen Reports on Outcome of FDA Meeting. Vasogen press release - June 27, 2007.

[edit] External links

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