Abstract
In 1997, Bulmer et al. [1] proposed a new procedure consisting n placing 10mL of anticoagulated (+2mL sodium citrate) of the atient’s venous blood in a VC7000A system (CelacadeTM, Vasogen nc., Mississauga, ON, Canada) where it was exposed to an oxyen/ozone gasmixture (ozone concentration 15.35g/m3) delivered nto the blood at a flow of 240mL/min and UV light (253.7nm) at a emperature of 42.5 ◦C for about 20min. The treated blood sample as removed from the system and immediately administered by ntragluteal injection to the donor patient. Two treatments were iven on consecutive days, followed by a third on day 14. Subseuent treatments were given at 4-week (28 days) intervals for at east 22 weeks, for a total of 8 injections. The procedure uses an expensive device able to deliver an enorously toxic dose of ozone (107.5mg per mL of blood) plus an ndetermined UV irradiation at 42.5 ◦C. The final ozone dose is bout 15,000-fold higher than the average ozone dose used durng the classical ozonated autohemotherapy [2] and the extremely igh oxidation of blood causes a complete denaturation of blood omponents [3]. This procedure was invented aiming to estabish a non-specific immunomodulation therapy (IMT) in the hope f reducing the inflammatory process and the chronic oxidative tress present in vascular disease. It has proved to be useless in n AIDS trial [4] and in a multicenter, randomized, double-blind, lacebo-controlled study in533patientswith symptomaticperiphral arterial disease (PAD), called the SIMPADICO trial [5]. It is ost important noting that this trial had to be stopped 3 months arly because it did not show any improvement in PAD and caused significantly higher rate of malignancies in the IMT group [6]. lthough in a pilot study [7] of 73 patients with heart failure the MT seemed to result in a reduction of mortality, a subsequent
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