Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-05-06
2001-07-24
Isabella, David J. (Department: 3738)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C128S898000, C250S43200R, C250S435000, C250S50400H, C604S500000
Reexamination Certificate
active
06264646
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to treatment of blood, and to the use of treated, modified blood in connection with certain abnormal mammalian physical conditions and disease states. More specifically, it relates to modified mammalian blood and the treatment of cardiovascular disorders associated with elevated levels of lipids in the blood, in a mammalian subject, by administration to the subject of such modified blood.
BACKGROUND OF THE INVENTION
Hyperlipidemias such as hypercholesterolemia and elevated serum triglyceride levels are among the most potent risk factors in the causation of atherosclerosis, which is the build-up of fatty plaque deposits within the walls of blood vessels. For example, nigh levels of serum cholesterol bound to low density lipoprotein (LDL), intermediate density lipoprotein (IDL) or very low density lipoprotein (VLDL) are known to correlate strongly with the occurrence of atherosclerosis in humans. In particular, it is believed that the higher the circulating levels of cholesterol in the form of LDL, IDL and VLDL cholesterol, and the higher the circulating levels of other lipids such as triglycerides, the more likely it is that cholesterol and lipids will be deposited within the blood vessel wall and cause or contribute to atherosclerosis
In hypercholesterolemia, for example, the increase in the blood cholesterol level is associated mainly with a rise in the concentration of LDL, IDL and VLDL cholesterol. However, the specific causes of hypercholesterolemia are complicated and varied. At least one kind of hypercholesterolemia, known as familial hypercholesterolemia, is caused by a mutation in the gene for the LDL receptor that moves cholesterol out of the blood, primarily in the liver. Much more commonly, hypercholesterolemia has been associated with high dietary intake of saturated fatty acids and cholesterol, resulting in elevated blood cholesterol levels. High serum triglyceride levels have also been associated with high dietary intake of fatty acids.
Reduction of hyperlipidemia, including hypercholesterolemia, results in a delayed onset of atherosclerosis and a decrease in the progression of atherosclerosis, thus reducing the risk of coronary heart disease. In addition, there is evidence that relatively complicated plaques induced by hyperlipidemia can regress, and that further progression of atherosclerosis will decrease or cease when hyperlipidemia is removed. Some forms of hyperlipidemia, including hypercholesterolemia, are potentially partially reversible with current techniques of preventive management. Taking cholesterol-lowering drugs can result in a reduction in serum cholesterol, and other drugs may lower serum triglyceride levels. However, drugs are not always warranted for hyperlipidemia, and some lipid-lowering drugs may have serious side effects. Dietary therapy is usually recommended for all patients with hyperlipidemia but the effect is often not sufficient to reduce risk optimally.
Therefore, there is a need for a method which is effective in lowering blood lipid levels, especially cholesterol and triglyceride levels, and which does not have significant side effects.
SUMMARY OF THE INVENTION
The present invention overcomes at least some of the above-noted and other disadvantages of presently known therapies for treatment of hyperlipidemia, such as hypercholesterolemia and elevated serum triglyceride levels, by providing a method for treating hyperlipidemia in which an aliquot of mammalian blood is treated ex vivo and subsequently introduced into the body of a mammalian subject.
The aliquot of blood is treated by being subjected to one or more stressors which have been found to modify the blood. According to the present invention, the blood aliquot can be modified by subjecting the blood, or separated cellular or non-cellular fractions of the blood, or mixtures of the separated cells and/or non-cellular fractions of the blood, to stressors selected from heat, ultraviolet light and oxidative environments such as treatment with ozone/oxygen mixtures, or any combination of such stressors, simultaneously or sequentially.
The observed effects of the modified blood of the present invention, when introduced into the mammalian subject's body, are several in number. Firstly, there is an observed reduction in total serum cholesterol levels, primarily due to a reduction in the levels of LDL and VLDL cholesterol. Levels of beneficial HDL cholesterol are not reduced. Reductions in cholesterol levels of as high as about 40 percent, as compared to subjects which received untreated blood as a placebo, have been observed. Secondly, there is an observed reduction in serum triglyceride levels. Such reductions in serum cholesterol and triglycerides would be expected to delay the onset and retard the progression of atherosclerosis due to hyperlipidemia.
Another of the observed effects of the treatment according to the present invention is that mammalian subjects treated according to the present invention show substantially reduced deposition of lipids within blood vessel walls, as compared to untreated subjects. As well as retarding the progression of plaque deposition, the treatment of the invention has been shown to cause existing plaques to regress. It is believed that this observed vessel protection is due at least in part to the reduced serum lipid levels in subjects treated by the method of the present invention. However, the reduced deposition of lipids within blood vessel walls has also been observed in the absence of a reduction in serum lipids.
Accordingly, in one aspect the present invention provides a method of reducing the serum level of a lipid in a mammal, comprising; (a) treating an aliquot of mammalian blood ex vivo with at least one stressor selected from the group consisting of a temperature above or below body temperature, ultraviolet light and an oxidative environment; and (b) administering the aliquot of blood treated in step (a) to the mammal, wherein the aliquot has a volume sufficient to achieve a reduction in the serum lipid level in the mammal.
In another aspect, the present invention provides a method of preventing or treating a condition in a mammalian subject, said method reducing the serum level of a lipid in the mammal and comprising (a) treating an aliquot of mammalian blood ex vivo with at least one stressor selected from the group consisting of a temperature above or below body temperature, ultraviolet light and an oxidative environment; and (b) administering the aliquot of blood treated in step (a) to the mammal, wherein the aliquot has a volume sufficient to achieve a reduction in the serum lipid level in the mammal.
REFERENCES:
patent: 4831268 (1989-05-01), Fisch et al.
patent: 4968483 (1990-11-01), Müller et al.
patent: 5591457 (1997-01-01), Bolton
patent: 5834030 (1998-11-01), Bolton
patent: 2194485 (1996-11-01), None
patent: 1 068 428 (1959-11-01), None
patent: WO 93/15778 (1993-08-01), None
patent: WO 98/07436 (1998-02-01), None
Burns Doane , Swecker, Mathis LLP
Isabella David J.
O'Hara Kelly
Vasogen Ireland Limited
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