Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Waste or feces
Reexamination Certificate
1999-09-24
2001-10-16
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Waste or feces
C424S520000, C424S537000, C128S202250, C514S885000
Reexamination Certificate
active
06303154
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods for the chemical modification of mammal urine and mammal blood. The modified blood or the modified urine have immune modulatory effects when administered to a mammal and can be used for the treatment of immune discorders.
BACKGROUND OF THE INVENTION
Mammal blood is known to consist of a cellular and a non cellular fraction. The non cellular fraction in non hemolytic blood is called plasma, a watery solution of minerals and complex biochemical synthesis products such as proteins (derived mostly from the liver and in form of immuneglobulines from cells of the immune system), carbohydrates, proteoglycans etc.
The cellular phase can be separated by centifugation or spontaneous sedimentation of the blood cell components and yields mostly erythrocytes and thrombocytes and a smaller fraction of leukocytes. Those can be differentiated in granulocytes and lymphocytes. Newer research has turned especially to the subgroups of the lymphocytes through flow cytometry. After specific staining of surface antigens it has been possible to identify different groups of cells among these. Cells with CD4 were called T-Helper cells (inducing and increasing immune activity), CD8 Cells were called T supressor or cytotoxic cells (reducing and controlling immune activity). A further discrimination of T helper cells in Th1 and Th2 cells was possible. Th1 cells produce preferential proinflammatory cytokins like interleukin 2, interferon gamma and tumor necrosis factor. Th1 cells are used for the attack of intracellular target antigens and tumor cells by their cytotoxic activity. The action of Th2 cells is preferential anti-inflammatory, they are producing Interleukin (IL) 4, IL 10 and IL 13. Th2 cells are used for the control of extracellular antigens. By the interaction of the Th1, the Th2 and the antigen presenting cells, the effector action of the immune system is controlled. Interferon gamma echances the production of prionflammatory substances as tumor necrosis factor, IL 1, IL 6, IL 12oxygen radicals an NO. IL 4 is counteracting the proinflammatory activity of these substances. Different groups of diseases show typical shifts of the balance in favor of Th1 or Th2 cells. A shift in favor of the Th1 cells is considered positive for tumor patients (anti tumor activity) but noxious for patients with organ specific automimmune diseases (like rheumatoid arthritis, uveitis, thyreoiditis). A predominance of Th2 cells will be noxious for allergic disease (Eczema), immune globulin mediated diseases and sclerodermia. This is considered as a possible explanation for the fact, that patients with active allergies and neurodermatitis are less prone for cancer. The pathologic activity and overweight of parts of the immune system in patients with allergic skin or lung disease, rheumatic and other autoimmune disease as well as many types of cancer has led to search for complex immunemodulatory agents that can rebalance that causing unbalance to influence the resulting disease.
Mammal urine or alternatively ultrafiltrate of dialysis treatments contain a spectrum of proteins and proteoglycans and other substances that pass physiologically the kidney filter. The substances are complex and differ in size and biologic function. A lot of urine substances probably have a biologic effect, but the subcutaneous administration of sterile urine of the same host mammal has not shown mentionable effects on the cells of the immune system. The same applies to the addition of sterile urine to leukocyte cultures of the same individual, no remarkable immunemodulatory effect was observed.
U.S. Pat. No. 4,632,980 (Zee et al.) discloses a method for virus inactivation of blood and blood products comprising treatment with low levels of ozone. Atfer virus inactivation the blood components are further separated and it can be used for the intended purpose.
U.S. Pat. No. 4,684,521 (Edelson) discloses a method and system for externally treating blood. It comprises treatment of blood with UV radiation in the presence of a photoactive agent.
U.S. Pat. No. 4,748,120 (Wiesehahn) discloses a method for the treatment of biological compositions with psoralen derivatives under irradiation conditions.
BRIEF DESCRIPTION OF THE INVENTION
It has now been found that oxidation of blood and urine under special conditions yeild a reliable substance for the treatment of disorders of the immune system. In one embodiment the present invention provides a method for chemical modification of mammal urine comprising the steps of
collecting urine from a mammal,
treating said mammal urine with an oxidizing agent and a gas atomosphere of at least 90% to 100% (v/v) oxygen in a container,
adding at least one protease,
removing substances with a low molecular weight to yield a modified mammal urine.
In a second embodiment the present invention provides a method for chemical modification of mammal blood comprising the steps of
collecting blood from a mammal,
separating the blood in a plasma phase and a cell phase,
treating of the plasma phase, the cell phase or both with an oxidizing agent and a gas atmosphere of about 90% to 100% (v/v) oxygen in a container,
combining the plasma phase with the cell phase,
adding a cell culture medium and at least one protease,
adding modified mammal urine prepared according to the first embodiment,
incubating for 16 to 36 hours at about 37° C.,
adding a preservation agent to yield modified mammal blood.
In a third embodiment the invention provides a method of treating immune disorders comprising the step of administering to a patient in need thereof modified mammal urine prepared according to the method of the invention.
In a fourth embodiment the invention provides a method of treating immume disorders comprising the step of administering to a patient in need thereof modified mammal blood prepared according to the method of the invention.
In a fifth embodiment the present invention provides the substance being able to modulate the immune system.
REFERENCES:
patent: 5052382 (1991-10-01), Wainwright et al.
patent: 5651993 (1997-07-01), Edelson et al.
patent: 195-12-027 (1996-10-01), None
patent: 195 26 112A1 (1997-01-01), None
patent: 0265548A1 (1988-05-01), None
patent: 0607593A2 (1994-07-01), None
Partial Translation of EP 0607593A2.
Partial Translation of EP 0265548A1.
Breivogel Boris
Kief Horst
Flood Michele
Jacobson & Holman PLLC
Tate Christopher R.
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