Celacade
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]
References
- ↑ "VasoCare. Vasogen". Current Opinion Investigational Drugs 2001.
- ↑ "Immune modulation therapy-peripheral vascular disease--Vasogen (VasoCare)". Drugs in Reasearch and Development 2002.
- ↑ "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.
- ↑ "Effects of VasoCare therapy on the initiation and progression of atherosclerosis". Journal of Atherosclerosis 2002.
- ↑ "Effect of combined heat, ozonation and ultraviolet irradiation (VasoCare) on heat shock protein expression by peripheral blood leukocyte populations". Biological Regulators & Homeostatic Agents 1997.
- ↑ "Chronic Heart Failure and the Immune System". Clinical Reviews of Allergy Immunology 2002.
- ↑ "Method of increasing the concentration of nitric oxide in human blood". United States Patent # 5,834,030.
- ↑ "Method of inhibiting the aggregation of blood platelets and stimulating the immune systems of a human". United States patent # 5,591,457. 1997.
- ↑ "Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression". American Journal Cardiology 2005.
- ↑ "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.
- ↑ "Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade™ in the European Union". Vasogen Inc April 18, 2007.
- ↑ "Vasogen Reports on Outcome of FDA Meeting". Vasogen press release - June 27, 2007.