Treatment of congestive heart failure

Inactive Publication Date: 2006-08-31
SMITH ELDON R +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0015] With respect to immune activation, the treatment of the present invention has been found to modulate levels of inflammatory cytokines in several Th1/TNF-α-dependent experimental inflammatory models in different species. For example, the treatment has been shown to reduce allergic contact hypersensitivity in Balb/c mice, a Th1-driven immune reaction mediated by TNF-α (Shivji et al., Journal of Cutaneous Medicine and Surgery 4: 132-137, 2000); to down-regulate expression of IL6 mRNA in adjuvant-induced arthritis in the Lewis rat model of inflammatory disease; and to decrease the proportion of Th1 to Th2 cells in patients with scleroderma, a Th1-driven autoimmune disease (Rabinovich et al., Poster presented at the XII Pan-American Congress of Rheumatology, Montreal, Canada, Jun. 21-25, 1998). It is believed that the treatment down-regulates the pro-inflammatory Th1-type immune response, for example by increasing anti-inflammatory TH2-type cytokines, including IL-10.
[0016] The treatment of the invention has been found to improve endothelial function in a number of studies conducted in humans and in animals. For example, the treatment has been found to improve endothelial-dependent vasodilator function in an open study on patients with severe primary Raynaud's disease (Cooke et al., International Journal of Angiology 16: 250-254, 1997), to improve the rate of recovery of skin blood flow fo

Problems solved by technology

The index event or other causes result in an initial decline in the pumping capacity of the heart, for example by damaging the heart muscle.
Therefore, the damaging changes caused by the disease are present and ongoing even while the patient remains asymptomatic.
In fact, the compensatory mechanisms which maintain normal cardiovascular function during the early phases of CHF may actually contribute to progression of the diseas

Method used

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  • Treatment of congestive heart failure
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  • Treatment of congestive heart failure

Examples

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Example

EXAMPLE 1

[0043] This example describes a study conducted to determine the effect of the treatment of the invention on endothelial function in Watanabe rabbits, known to develop complex atherosclerotic lesions during the first year of life. As previously mentioned, endothelial dysfunction is linked to the pathophysiology of CHF.

[0044] The rabbits entered the study at 7 to 8 months of age, and were randomized into three groups, a first group to be sacrificed immediately for baseline measurements, a second group (n=10) which received injections of blood treated according to the invention, and a third group (n=10) which received sham treatments comprising injections of untreated blood.

[0045] The treatment comprised a total of 4 injections of treated blood over a period of 10 weeks. The blood was treated by exposure to the following three stressors in an apparatus as generally described in U.S. Pat. No. 4,968,483 to Mueller et al.: [0046] (a) an elevated temperature of 42.5° C.±1.0° C...

Example

EXAMPLE 3

[0065] This example relates to the use of the treatment of the invention to prevent the onset of arthritis, and describes the results of a study conducted in an established animal model of arthritis. The specific animal model used in this study was adjuvant-induced arthritis in rats (see, for example, Pearson, C., 1956, “Development of Arthritis, periarthritis and periostitis in rats given adjuvant”, Proc. Soc. Exp. Biol. Med., 91:95). According to this model, arthritis is induced in rats by injecting them with adjuvant containing Mycobacterium butyricum.

[0066] Male Lewis rats, 4 to 5 weeks of age, 100 to 120 g, were obtained from Charles River Laboratories, quarantined one week and entered into the study. An adjuvant mixture was prepared for induction of arthritis by suspending 50 mg M. butyricum (Difco Laboratories, Inc., Detroit, Mich.) in 5 ml light white paraffin oil—m3516 (Sigma Chemical Co., St. Louis, Mo.) and thoroughly mixed using a homogenizer. Aliquots of the ...

Example

EXAMPLE 4

[0072] The experiment reported in this example demonstrates, by use of an animal model system involving ischemia and subsequent reperfusion of various body organs, that the treatment of the present invention has the effect of reducing apoptosis and necrosis. Ischemia-reperfusion injuries are known to involve increase of apoptosis and necrosis in the affected organs and tissues—see for example Salkumar p, et at. “Mechanisms of cell death in hypoxia / reoxygenation injury”, Oncogene Dec. 24, 1998; 17(25):3341-9; and Burns A. T. et. al., “Apoptosis in ischemia / reperfusion injury of human renal allografts”, Transplantation, Oct. 15, 1998; 66(7): 872-6, and other publications both preceding and following those. Known techniques of determination of apoptosis at the cellular level are employed in this example.

[0073] Pure-bred normal beagle dogs, aged 1-2 years, equal numbers of males and females, were used as the experimental animals. The animals were separated into four groups, A...

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Abstract

A method of treating congestive heart failure (CHF) in a human patient comprises treating an aliquot of the patient's blood ex vivo with at least one stressor selected from the group consisting of a temperature above or below body temperature, an electromagnetic emission and an oxidative environment, followed by administering the aliquot of treated blood to the patient. The treatment can be used on its own or as an adjunctive therapy in combination with conventional CHF treatments.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention relates to methods for treating congestive heart failure, in particular by the administration to a human subject of an aliquot of modified blood, optionally in combination with one or more other treatments for alleviating the symptoms of congestive heart failure. [0003] 2. Description of the Prior Art [0004] Congestive heart failure (CHF) is a relatively common disorder affecting approximately five million Americans, with a mortality rate of over 80,000 per year. It is believed that CHF is not a distinct disease process in itself, but rather represents the effect of multiple anatomic, functional and biologic abnormalities which interact together to ultimately produce progressive loss of the ability of the heart to fulfill its function as a circulatory pump. [0005] CHF may be caused by the occurrence of an index event such as a myocardial infarction (heart attack) or be secondary to other causes such a...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K35/14A61K31/44A61K45/00A61K31/444A61K31/454A61K31/522A61K31/573A61K31/70A61K31/7076A61K36/18A61K41/00A61P9/04A61P43/00C12N5/08
CPCA61K31/14A61K33/00A61K35/14A61K41/00A61K2300/00A61K41/0004A61K31/44A61K31/454A61K31/522A61K31/573A61K31/70A61K41/17A61P43/00A61P9/04
Inventor SMITH, ELDON R.TORRE-AMIONE, GUILLERMO
Owner SMITH ELDON R
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