WO1998050051A1 - Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia - Google Patents
Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia Download PDFInfo
- Publication number
- WO1998050051A1 WO1998050051A1 PCT/US1997/007122 US9707122W WO9850051A1 WO 1998050051 A1 WO1998050051 A1 WO 1998050051A1 US 9707122 W US9707122 W US 9707122W WO 9850051 A1 WO9850051 A1 WO 9850051A1
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- Prior art keywords
- vitamin
- meg
- sickle cell
- treating
- person
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
Definitions
- the present invention is a continuation of the inventors first patent and relates to the treatment and prophylaxis of hemoglobin disorders and extends that treatment to the problems associated with the immune system failures and organ failures that occur along with sickle cell anemia. More particularly, the present invention provides a tailored preventative and/or maintenance treatment regimen for an individual suffering from genetic sickle cell disease or immune system failures for other reasons. This particular invention is specifically directed at treating organ failures and infections that occur in sickle cell anemia and suggest that the treatment may be used in conditions like AIDS, Diabetes, Lupus and other conditions with similar problems.
- sickle cell disease is a generic term for a group of genetic disorders characterized by the predominance of hemoglobin S (Hb S). These disorders include sickle cell anemia, the sickle beta thalassemia syndromes, and hemoglobinopathies in which Hb S is in association with another abnormal hemoglobin.
- Hb S hemoglobin S
- the two beta globulin genes located on chromosome 11 and the four alpha globulin genes located on chromosome 16 determine hemoglobin production. Normal red blood cells are produced in individuals who carry all four alpha globin genes and two normal beta globin genes ( ⁇ A).
- Carriers of the sickle cell trait who do not normally physically express the disease, have a normal beta globin gene and a ⁇ S globin gene, resulting in the production of both normal hemoglobin A and hemoglobin S, with a predominance of Hb A.
- Individuals who are homozygous for the sickle beta globin gene ( ⁇ S) have sickle cell anemia (Hb SS).
- Individuals with sickle beta thalassemia have a ⁇ S gene and a gene for beta thalassemia, ⁇ thal.
- Those who have two abnormal beta globin genes, ⁇ S and ⁇ C produce hemoglobins Hb S and Hb C, and have Hb SC disease.
- the absence of two of the alpha globin genes results in alpha thalassemia. Abnormalities in both the beta and alpha genes may be present in the same individual.
- Red blood cells of sufferers of sickle cell disease are prone to distortions in geometry when deoxygenated. This distortion arises from the polymerization or gelling of Hb S molecules into elongated microtubular structures. Hb S is more susceptible to polymerization in the deoxygenated state than hemoglobin A due to the substitution of a hydrophobic residue valine for a polar residue glutamic acid in Hb A. These distortions of red blood cells, or sid ling, leads to chronic hemolytic anemia and vaso-occlusion resulting in ischemic tissue injury.
- Hemolytic anemia is caused by abnormal properties of Hb S and/or by repeated cycles of sideling and unsickling, which interact to produce irreversible red cell membrane changes and erythrocyte destruction.
- Tissue injury is usually produced by hypoxia secondary to obstruction of blood vessels by an accumulation of sickled erythrocytes.
- the organs at greatest risk are those with venous sinuses where blood flow is slow and oxygen tension and pH are low (spleen, kidney, bone marrow) or those with a limited terminal arterial blood supply (eye, head of the femur).
- Symptoms of the hypoxic injury may be either acute (e.g., painful events, acute chest syndrome) or insidious in onset (e.g., aseptic necrosis of the hips, sickle cell retinopathy).
- acute and chronic tissue injury may ultimately result in organ failure, particularly as the patient ages.
- US Patent No. 5,114,972 issued May 19, 1992 to Tsuyoshi Ohnishi describes the anti-oxidant and anti-cancer activity of prostaglandin derivatives of ascorbic acid.
- US Patent No. 4,629,625, issued December 16, 1986 to Gerald Gaull describes compositions including vitamins and/or minerals in combination with taurine, a compound synthesized in animal tissues, useful in providing a protective action on cell membranes.
- US Patent No. 5,364,644, issued November 15, 1994 to Zbigniew Walaszek et al. describes methods for lowering cholesterol with D-glucarate which may include a multiplicity of vitamins, minerals, and micronutrients.
- the present invention is based on the finding that a maintenance regimen with controlled intake of particular vitamin, mineral, and micronutrient formulations, drastically reduces the incidence and severity of sickle cell disease crises.
- the formulations useful in the present invention include vitamin A, vitamin B-l, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin E, niacinamide, para-aminobenzoic acid (PABA), pantothenic acid, choline bitartrate, inositol, rutin, citrus bioflavonoid complex, betaine hydrochloride, hesperidin complex, folic acid, biotin, calcium, iron, magnesium, zinc, potassium, manganese, iodine, chromium, selenium, and a pharmaceutically acceptable carrier.
- vitamins and minerals are administered at or just below critical saturation levels which may be determined for each individual by establishing a base line dosage level of multiple vitamins and minerals over a period of days; adjusting this base line dosage upwards until the manifestation of easily observed responses; and finally reducing the dosage slightly until such manifestations disappear. Accordingly, the daily doses for some of these vitamins, minerals, and micronutrients will exceed those conventionally considered necessary as dietary or nutritional supplements.
- the present method triggers an increase in the production of viable hemoglobin, and alters the overall blood profile.
- Platelet concentration is increased up to about twice that observed in normal blood, and the red blood cells produced display increased resistance to sideling. This enhanced biosynthesis is achieved by providing sufficient stores of precursors that stimulate low level manufacture without substantial feedback control by the upper central nervous system.
- the present invention provides a method of treating persons having sickle cell disease however the treatment is not limited to persons with sickle cell anemia. While this treatment has been tested and proven to be effective in persons with sickle cell anemia, the process was designed to work as a immune system enhancement
- the dosage range specified below is the range found to be effective in persons with sickle cell anemia. Persons with AIDS, and other type deficiencies will have different ranges and those ranges will have to be established through additional test.
- the effective daily dosage at saturation of each vitamin or mineral falls within the following ranges for persons with sickle cell anemia:
- Vitamin B-l 25-1000 mg.
- Vitamin B-2 25-1000 mg.
- Vitamin B-6 25-1000 mg.
- Vitamin C 25-1000 mg.
- Vitamin E 25-1000 LU Vitamin E 25-1000 LU.
- PABA Para-aminobenzoic acid
- Pantothentic Acid 25-1000 mg.
- the normal range of conditions for body surface temperature, frequency of urination, sleep and physical activity should be established prior to practicing the present method. Persons of six years of age or younger, with the disease of sickle cell, should start with the minimum dosage listed above, those of from 7-15 years of age, twice that amount, and those over 15 years of age four times that amount.
- This selected base daily dosage is administered for an initial period of from 3-10 days, and the conditions established for the person are monitored. Deviations outside the established range for these conditions indicate that saturation has been surpassed, and the dosage should be reduced, preferably by up to half.
- the base daily dosage may be gradually adjusted upward to a modified daily dosage with each succeeding 3-10 day period, in increments of from about 1 to about 100 percent, if the above noted conditions stay within the normal range established. Should the conditions in any period deviate outside the established range, a downward adjustment of about 1 to 50 percent should be made.
- the relative proportions of these components is maintained as the dosage is increased or decreased.
- an increase in urination rate to twice normal, loss of sleep, marked hyperactivity, and/or a perceptible increase in the body surface temperature of the skin to the touch without any systemic fever indicate that the saturation level has been surpassed.
- a brightening of the eyes is a normal effect of the present inventive method, and overnight loss of tint in the whites of the eyes during the initial period or any subsequent period may be also used as an indication to reduce the dosage.
- the increments chosen for each succeeding modified daily dosage should be reduced until a first modified daily dosage is found, in which no deviation of conditions outside the normal range is perceived.
- the first modified daily dosage is within from about 1 to 10 percent of a second modified dosage in which conditions deviate beyond normal. At that point, the fist modified daily dosage is selected and used for continuous administration.
- Sustained-release formulations of the above ingredients such as polymer matrix tablets, liquid gel compositions, sprays and powders may be used, and are ideally suited for maintaining a dosage at or near saturation level, once determined.
- These formulations may include an inert pharmaceutically acceptable carrier.
- the carrier is a base selected from one or more of rice, papaya, water crest, parsley, kelp, alfalfa, cabbage, cherry, wheat flower, or bromelain. It should be noted that powders seem to perform the least and seems to sometimes gives false indications. Sprays are being tested for immediate relief. The very best performer is Sustained release a second best are gel forms.
- Mineral ingredients are preferably provided as amino acid chelates. Trace amounts of additional chelate materials may also be present, including actinium, aluminum, antimony, barium, beryllium, bismuth, boron, bromine, cadmium, cerium, cesium, chlorine, cobalt, copper, dysprosium, erbium, europium, fluorine, gadolinium, gallium, germanium, gold, hafnium, holmium, indium, iridium, lanthanum, lithium, lutetium, molybdenum, neodymium, nickel, niobium, osmium, palladium, phosphorous, platinum, praseodymium, rhenium, rhodium, rubidium, ruthenium, samarium, scandium, silicon, silver, sodium, strontium, sulfur, tantalum, tellurium, terbium, thallium, thorium, tin, titanium, tungsten,
- kits may be used that includes individual tablets or capsules each with the minimum amounts, or integer factor thereof, of the vitamins, minerals, and micronutrients, already in combination, and in a suitable pharmaceutical carrier.
- forms and/or charts may be provided that include space for recordation of conditions at associated daily doses.
- This kit may further include detailed instructions for carrying out the present method in any appropriate media, as well as any information regarding the formulation.
- the administration of a daily saturation dosage when continuously maintained provides an effective sickle cell crisis preventative measure that may be practiced outside a critical care environment. This allows persons suffering from sickle cell disease to lead more productive, normal lives. The constant threat of crisis onset is dramatically reduced, thereby contributing to greater mental and emotional confidence.
- a patient diagnosed with Sickle Cell Anemia was treated with conventional methods including the use of transfusions, antibiotics, acetaminophen, and codeine. Despite these treatments sickle cell crises were frequent, resulting in hospitalizations for severe fevers and multiple organ failures.
- this daily dosage regimen was temporarily interrupted under medical direction, and conventional treatment was reinstated.
- sickle cell crises returned in a frequency and at a level of severity at least as great as encountered before age 7, resulting in retinal detachment, and the loss of one of the patient's eyes.
- Conventional treatment was again ceased and experimental daily dosage "B" was administered.
- sickle cell crises were drastically reduced and no additional hospitalizations were required while practicing the present regimen.
- the person has been able to participate in exercises and dance competitions.
- she has taken flight lessons with no apparent problems. She has been able to perform as though the disease no longer existed within her while on this regiment. All symptoms of the disease disappears while on this regiment.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/516,737 US5626884A (en) | 1995-08-18 | 1995-08-18 | Treatment of sickle cell disease |
PCT/US1997/007122 WO1998050051A1 (en) | 1995-08-18 | 1997-05-05 | Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia |
AU29932/97A AU2993297A (en) | 1995-08-18 | 1997-05-05 | Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/516,737 US5626884A (en) | 1995-08-18 | 1995-08-18 | Treatment of sickle cell disease |
PCT/US1997/007122 WO1998050051A1 (en) | 1995-08-18 | 1997-05-05 | Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998050051A1 true WO1998050051A1 (en) | 1998-11-12 |
Family
ID=26792493
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/007122 WO1998050051A1 (en) | 1995-08-18 | 1997-05-05 | Treatment of sickle cell disease, treatment of immune system diseases and other diseases normally associated with sickle cell anemia |
Country Status (3)
Country | Link |
---|---|
US (1) | US5626884A (en) |
AU (1) | AU2993297A (en) |
WO (1) | WO1998050051A1 (en) |
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US4904678A (en) * | 1987-08-25 | 1990-02-27 | Jerome J. Norris | Sickle cell anemia control |
US5364644A (en) * | 1990-05-16 | 1994-11-15 | Board Of Regents, The University Of Texas System | Formula and method for the prevention and treatment of hypercholesterolemia and cellular hyperproliferative disorders |
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WO2000025764A3 (en) * | 1998-10-30 | 2000-07-13 | Merck Patent Gmbh | Compositions for the treatment and prevention of cardiovascular diseases |
US9808441B2 (en) * | 1999-11-06 | 2017-11-07 | Janmarie Hornack | Dietary supplement containing alkaline electrolyte buffers |
CN107184859A (en) * | 2017-07-25 | 2017-09-22 | 江西熙帝生物科技有限公司 | A kind of composition with three high drop and anti-trioxypurine |
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US5626884A (en) | 1997-05-06 |
AU2993297A (en) | 1998-11-27 |
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