Abstract: Acellular amnion derived therapeutic compositions are described having a number of various compositional embodiments. An acellular amnion derived therapeutic composition has essentially no live or active amniotic cells. The amniotic cells may be destroyed and the cells and cell debris may be removed from the acellular amnion derived therapeutic composition. An acellular amnion derived therapeutic composition may comprise micronized placental tissue particles, and/or amniotic fluid. An acellular amnion derived therapeutic composition may be a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like. An acellular amnion derived therapeutic composition may be combined with a matrix component to form a composite. An acellular amnion derived therapeutic composition may be used in conjunction with a composition comprising viable cells, such as stem cells.

Abstract: A method and system for determining a treatment outcome prediction for a patient using electroencephalograph (EEG) are disclosed, which include analyzing a brain region mutual interaction characteristics using scalp EEG data from a patient and obtaining a set of brain region mutual interaction feature matrices, performing a feature enhancement process to the brain region mutual interaction feature matrices to extract prominent mutual interaction features and applying a treatment response predictive model to determine a treatment outcome prediction for the patient. Further disclosed is a method of generating a treatment response predictive model using EEG dataset of a group of patients under a clinical treatment. The method and system can be used for determining a treatment outcome prediction for a psychiatric disorder patient and a patient diagnosed with COVID-19 and suffering from psychiatric disorder symptom(s) originated from COVID-19.

Abstract: Described herein are compositions composed of micronized placental components and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the micronized compositions are also described herein.

Abstract: The present disclosure provides compositions composed of amniotic fluid and/or modified amniotic fluid, a pharmaceutically acceptable carrier, and optionally a placental tissue graft, micronized placental tissue components, or extracts derived therefrom. Also described are systems and apparatuses for administering or storing said compositions, as well as methods of treatment using said compositions.

Abstract: Acellular amnion derived therapeutic compositions are described having a number of various compositional embodiments. An acellular amnion derived therapeutic composition has essentially no live or active amniotic cells. The amniotic cells may be destroyed and the cells and cell debris may be removed from the acellular amnion derived therapeutic composition. An acellular amnion derived therapeutic composition may comprise micronized placental tissue particles, and/or amniotic fluid. An acellular amnion derived therapeutic composition may be a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like. An acellular amnion derived therapeutic composition may be combined with a matrix component to form a composite. An acellular amnion derived therapeutic composition may be used in conjunction with a composition comprising viable cells, such as stem cells.

Abstract: Provided herein are methods and compositions for treating metabolic diseases and conditions associated with metabolic diseases.

Abstract: The invention relates to a method for inhibiting euPTX3 to treat nasopharyngeal carcinoma by an amino acid sequence, comprising administering an effective amount of the amino acid sequence to a subject in need. The amino acid sequence can be used to inhibit euPTX3 from promoting the migration and invasion of nasopharyngeal carcinoma cells, promoting angiogenesis and inhibiting macrophage phagocytosis to further treat nasopharyngeal carcinoma.

Abstract: Methods of preparing sterile de-cellularized human amniotic fluid that is amenable for long-term storage without loss of biological functions have been developed. In particular, the methods involve refrigeration steps to maximize shelf-life while retaining most of the important growth factors and other molecules present in the fresh amniotic fluid for effective therapeutic application. Use of the compositions is intended for therapeutic purposes and will alleviate pain or discomfort associated with any disorders or diseases, particularly those involving eyes and joints, or fibrotic disorders such as COPD.

Abstract: A skin treatment method, including: performing a skin treatment procedure on the skin of a patient, wherein the skin treatment procedure includes one of a chemical peel procedure, a dermabrasion procedure, a micro-needling procedure, and a laser procedure; and subsequently, applying a preparation including one or more of amniotic fluid and amniotic membrane material to the treated skin of the patient to promote healing and collagen rejuvenation, wherein the preparation including the one or more of amniotic fluid and amniotic membrane material is prepared from one or more of amniotic fluid, a concentrated amniotic membrane solution, and an amniotic membrane powder. The preparation comprising the one or more of amniotic fluid and amniotic membrane material also includes sterile water or saline. The treated skin of the patent preferably includes one or more of the skin of the face and the skin of the neck.

Abstract: A bear bile macromolecular extract with anti-HCV virus function is disclosed. A preparation method comprises the following steps of: taking fresh bear bile or dissolving bear bile powder with water, centrifuging it by a molecular sieve filter membrane with molecular weight cut-off of 100,000 or an ultrafiltration membrane, filtering to obtain sediment, dissolving the sediment with water, adding the solution to sephadex column, separating the solution by using water or buffer as elution solvent, and freeze-drying the eluent to obtain the bear bile macromolecular extract. Experiments show that the bear bile macromolecular extract has anti-HCV virus function and can be used for treating hepatitis C.

Abstract: Embodiments of methods of treating atherosclerosis are described. In some embodiments an emulsifier is provided to achieve levels in the systemic circulation that are effective to solubilize atherosclerotic plaque, resulting in plaque regression. In some embodiments, levels of greater than 50 ?M are achieved; in some embodiments levels ranging from about 100 ?M to about 600 ?M are achieved; in some embodiments, levels ranging from about 100 ?M to about 300 ?M are achieved. Emulsifiers can include bile salts, saponins, and ionic, nonionic, and zwitterionic detergents, or salts, conjugates, hydrates, solvates, or polymorphs thereof. In some embodiments, a statin can be administered simultaneously or sequentially with an emulsifier.

Abstract: Serum compositions for application to endothelial tissue are described which contain an amniotic fluid extract in combination with embryonic stem cells. Formulations containing the serum composition are also described. The serum compositions and formulations may be used to treat conditions of the mouth such as dry mouth and mouth sores.

Abstract: Serum compositions for application to skin are described which contain an amniotic fluid extract in combination with embryonic stem cells. Formulations containing the serum composition are also described. The serum compositions and formulations may be applied to skin for treatment of symptoms of aging, wounds, burns, scars or other skin lesions. Methods of preparing the serum compositions and formulations are also disclosed.

Abstract: The disclosure includes assays and methods for screening for risk of Down syndrome and/or trisomy 21 in a fetus. The assays and methods comprise determining the level of at least one biomarker selected from mucin 13 (MUC13), bile salt-activated lipase (CEL), dipeptidyl peptidase 4 (DPP4), carboxypeptidase A1 (CPA1), amyloid precursor protein (APP) and tenascin-C (TNC-C) polypeptides in a test biological sample from a pregnant subject, wherein a decreased level of MUC13, CEL, DPP4, and/or CPA1 polypeptide and/or an increased level of APP and/or TNC-C polypeptide in the test biological sample compared to a corresponding reference biomarker polypeptide level indicates an increased risk of Down syndrome or trisomy 21 in the fetus. The disclosure also includes assays, compositions, immunoassays, and kits for performing the methods disclosed herein.

Abstract: Improved methods for heart transplant are described. The methods utilize an allograft comprising a layer of amnion to improve the performance and reduce complications of the heart transplant surgery and the allograft has a pre-made size and shape suitable for the application.

Abstract: Aspects of the invention provide methods for treatment of nonalcoholic steatohepatitis and associated liver fibrosis. In particular, aspects of the invention relate to the use of a therapeutic formulation comprising a galacto-rhamnogalacturonate compound for the treatment of nonalcoholic steatohepatitis and associated liver fibrosis.

Abstract: The present invention provides anticancer biological response modifier combinations. In accordance with an aspect of the present invention, there is provided a combination comprising: (i) a composition comprising small molecular weight components of less than 3000 daltons, and having the following properties: is extracted from bile of animals; is capable of stimulating monocytes and/or macrophages in vitro and/or in vivo; is capable of modulating tumor necrosis factor production and/or release; contains no measurable level of IL-1?, IL-1?, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma; is not cytotoxic to human peripheral blood mononuclear cells; is not an endotoxin; and (ii) one or more anticancer agent(s), wherein said combination has therapeutic synergy or improves the therapeutic index in the treatment of cancer over the composition or the anticancer agent(s) alone.

Abstract: The present invention concerns pharmaceutical compositions and methods for treating proliferative diseases, e.g. cancer using intracellular and extracellular extracts.

Abstract: Serum compositions for application to skin are described which contain an amniotic fluid extract in combination with embryonic stem cells. Formulations containing the serum composition are also described. The serum compositions and formulations may be applied to skin for treatment of symptoms of aging, wounds, burns, scars or other skin lesions. Methods of preparing the serum compositions and formulations are also disclosed.

Abstract: A method for treating a cancer, by determining a patient to have an ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 and selecting that patient for treatment, and administering to the patient an effective amount of an immunomodulating composition comprising small molecular weight components of less than 3000 daltons, and having the following properties: (i) is extracted from bile of animals; (ii) is capable of stimulating monocytes and/or macrophages; (iii) is capable of modulating tumor necrosis factor production and/or release; (iv) contains no measurable level of IL-1?, IL-1?, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-?; (v) is not cytotoxic to human peripheral blood mononuclear cells; and (vi) is not an endotoxin. A method of increasing the survival rate of a cancer patient.

Abstract: Embodiments of methods of treating atherosclerosis are described. In some embodiments an emulsifier is provided to achieve levels in the systemic circulation that are effective to solubilize atherosclerotic plaque, resulting in plaque regression. In some embodiments, levels of greater than 50 ?M are achieved; in some embodiments levels ranging from about 100 ?M to about 600 ?M are achieved; in some embodiments, levels ranging from about 100 ?M to about 300 ?M are achieved. Emulsifiers can include bile salts, saponins, and ionic, nonionic, and zwitterionic detergents, or salts, conjugates, hydrates, solvates, or polymorphs thereof. In some embodiments, a statin can be administered simultaneously or sequentially with an emulsifier.

Abstract: Provided herein are methods of treating spinal cord and traumatic brain injuries using cells from amnion, and populations of such cells, referred to herein as “amnion derived adherent cells” (“AMDACs”).

Abstract: A method for treating a cancer, by determining a patient to have an ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 and selecting that patient for treatment, and administering to the patient an effective amount of an immunomodulating composition comprising small molecular weight components of less than 3000 daltons, and having the following properties: (i) is extracted from bile of animals; (ii) is capable of stimulating monocytes and/or macrophages; (iii) is capable of modulating tumor necrosis factor production and/or release; (iv) contains no measurable level of IL-1?, IL-1?, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-?; (v) is not cytotoxic to human peripheral blood mononuclear cells; and (vi) is not an endotoxin.

Abstract: A bear bile macromolecular extract with anti-HCV virus function is disclosed. A preparation method comprises the following steps of: taking fresh bear bile or dissolving bear bile powder with water, centrifuging it by a molecular sieve filter membrane with molecular weight cut-off of 100,000 or an ultrafiltration membrane, filtering to obtain sediment, dissolving the sediment with water, adding the solution to sephadex column, separating the solution by using water or buffer as elution solvent, and freeze-drying the eluent to obtain the bear bile macromolecular extract. Experiments show that the bear bile macromolecular extract has anti-HCV virus function and can be used for treating hepatitis C.

Abstract: The present invention provides anticancer biological response modifier combinations. In accordance with an aspect of the present invention, there is provided a combination comprising: (i) a composition comprising small molecular weight components of less than 3000 daltons, and having the following properties: is extracted from bile of animals; is capable of stimulating monocytes and/or macrophages in vitro and/or in vivo; is capable of modulating tumor necrosis factor production and/or release; contains no measurable level of IL-1?, IL-1?, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma; is not cytotoxic to human peripheral blood mononuclear cells; is not an endotoxin; and (ii) one or more anticancer agent(s), wherein said combination has therapeutic synergy or improves the therapeutic index in the treatment of cancer over the composition or the anticancer agent(s) alone.

Abstract: The subject invention provides materials and methods for modulating a variety of biological factors to treat biological conditions associated with the factors. In one embodiment of the invention, a cysteamine compound is administered to a patient to treat hypercholesterolemia and/or complications associated with hypercholesterolemia. In another embodiment, a cysteamine compound is administered to a patient to prevent the onset of diabetes in an at-risk patient and/or treat or prevent the onset of diabetes-associated complications.

Abstract: Provided are nucleic acids comprising ABCB4 gene mutations (e.g., insertions, deletions, frame shift, missense) (e.g., canine ABCB4 1583_1584G) that result in prematurely terminated and/or inactive ABCB4 proteins. A significant association (P=1.54E-7) of the mutations was detected between gallbladder mucoceles-affected dogs, providing methods for detection or diagnosis of a hepatobiliary disease and/or related conditions (e.g., increased mucin secretion, mucinous hyperplasia, gallbladder mucocele, progressive familial intrahepatic cholestasis (type 3), cholelithiasis, primary biliary cirrhosis, and intrahepatic cholestasis of pregnancy). Compositions and methods for genotyping or screening of test subjects are provided, and have added utility in combination with surgical intervention, selective breeding, and medical or dietary management. Also provided are methods of treatment of dogs with hepatobiliary disease, comprising administration of hydrophilic, less cytotoxic bile acids (e.g., ursodeoxycholate).

Abstract: Means for improving the success rate of pregnancy on the basis of blastocyst transfer is disclosed. The means comprises an agent for promoting pregnancy in blastocyst transfer comprising the supernatant of the culture which is obtained by culturing a human embryo in a medium until the embryo develops into a blastocyst. Also disclosed are a method for production of the agent, as well as a method for promoting pregnancy comprising: culturing a human embryo in a medium until the human embryo develops into a blastocyst, injecting a composition comprising the supernatant of the culture into the uterine cavity of a patient who is to undergo blastocyst transfer, and then transferring the blastocyst to the recipient.

Abstract: Compositions and methods for the treatment of ocular disease and injury are provided. The methods involve the administration of amniotic fluid directly to the eye, for example, as eye drops. The types of diseases and injuries that can be treated in this manner include chemical burns, dry eye and corneal neovascular disorders, corneal opacities (including corneal haze) and inflammatory diseases of the eye.

Abstract: The present invention provides anticancer biological response modifier combinations. In accordance with an aspect of the present invention, there is provided a combination comprising: (i) a composition comprising small molecular weight components of less than 3000 daltons, and having the following properties: is extracted from bile of animals; is capable of stimulating monocytes and/or macrophages in vitro and/or in vivo; is capable of modulating tumor necrosis factor production and/or release; contains no measurable level of IL-1?, IL-1?, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma; is not cytotoxic to human peripheral blood mononuclear cells; is not an endotoxin; and (ii) one or more anticancer agent(s), wherein said combination has therapeutic synergy or improves the therapeutic index in the treatment of cancer over the composition or the anticancer agent(s) alone.

Abstract: The present invention is directed to methods of treating a human for a variety of conditions by administering an agonist of the G protein coupled receptor TGR5. In addition, the invention includes methods for determining whether a test compound is likely to be effective in treating one of these conditions by assaying it for its ability to raise intracellular iodothyronine deiodinase levels or for its ability to bind to and activate TGR5.

Abstract: Compositions for pharmaceutical and other uses comprising clear aqueous solutions of bile acids which do not form any detectable precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions. The compositions of the invention comprise water; a bile acid in the form of a bile acid, bile acid salt, or a bile acid conjugated with an amine by an amide linkage; and either or both an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of pH values and, according to one embodiment, remains in solution for all pH values obtainable in an aqueous system. The composition, according to some embodiments, may further contain a pharmaceutical compound in a pharmaceutically effective amount. Non-limiting examples of pharmaceutical compounds include insulin, heparin, bismuth compounds, amantadine and rimantadine.

Abstract: The present invention relates to the use of glutamic acid for the preparation of a nutritional preparation that is intended for use for the treatment or prevention of excess or undesired permeability of the intestinal wall. In particular, according to the invention the glutamic acid is used in a nutritional preparation, such as a baby food or an enteral food. Examples of conditions where glutamic acid is used are: food allergy, internal drug allergy, sepsis, low blood flow through the intestines, ICU patients, surgical interventions, malnutrition or intestinal maturation of newborn babies.

Abstract: The present invention relates to a composition for use as an immunomodulator comprising small molecular weight components of less than 3000 daltons, and having the following properties: a) is extractable from bile of animals; b) is capable of stimulating monocytes and macrophages in vitro; c) is capable of modulating tumor necrosis factor production; d) contains no measurable IL-1a, IL-1b, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma; e) has an anti-proliferative effect in a malignant mouse hybridoma cell line; f) shows no cytotoxicity to human peripheral blood mononuclear cells; and g) is not an endotoxin. The invention also relates to a method of preparing the composition and its use as an immunomodulator.

Abstract: A composition for treating diabetes is disclosed. The composition includes fenugreek and bile from the gallbladder of ruminant mammals. The composition is used to treat diabetes through regular periodic dose administration.

Abstract: The present invention relates to a composition for use as an immunomodulator comprising small molecular weight components of less than 3000 daltons, and having the following properties: a) is extractable from bile of animals; b) is capable of stimulating monocytes and macrophages in vitro; c) is capable of modulating tumor necrosis factor production; d) contains no measurable IL-1a, IL-1b, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma; e) has an anti-proliferative effect in a malignant mouse hybridoma cell line; f) shows no cytotoxicity to human peripheral blood mononuclear cells; and g) is not an endotoxin. The invention also relates to a method of preparing the composition and its use an immunomodulator.

Abstract: The present invention relates to a composition for use as an immunomodulator comprising small molecular weight components of less than 3000 daltons, and having the following properties: a) is extractable from bile of animals; b) is capable of stimulating monocytes and macrophages in vitro and in vivo; c) is capable of modulating tumor necrosis factor production; d) contains no measurable IL-1&agr;, IL-1&bgr;, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-&ggr;; e) has an anti-proliferative effect in a malignant mouse hybridoma cell line; f) shows no cytotoxicity to human peripheral blood mononuclear cells or lymphocytes; and g) is not an endotoxin. The invention also relates to a method of preparing the composition, its use as an immunomodulator, and its use in the treatment of diseases and conditions having an immunological component.

Abstract: A controlled release diltiazem dosage formulation comprising a plurality of active pellets coated with an extended release coating wherein the active pellets contain diltiazem or a pharmaceutically acceptable salt, a pharmaceutically acceptable inert seed and a binder and the extended release coating contains a water insoluble water permeable polymer, a channeling agent, a lubricant and optionally a surfactant. A single batch intermittent method of manufacturing a heterogeneous population of extended release pellets for use as a dosage formulation is also disclosed.

Abstract: Halophilic bacteria have been shown to cause red heat on brine-cured hides, resulting in extensive damage to leather made from the hides. The addition of bile salts to raceways or to hides directly has been found to prevent the occurrence of red heat by inhibiting the growth of the halophilic bacteria. Bile salt solutions were added to cultures of Haloarcula hispanica, Haloferax gibbonsii and Haloferax mediterranei. Fresh hides were also cured in brine containing halobacteria and bile salts. In both instances, the presence of bile salts inhibited the growth of halobacteria, and hides cured in the presence of halobacteria did not develop red heat.

Abstract: The present invention relates to a significant improvement in the preparation of a pharmaceutically purified and proven effective product of powdered bovine tracheal cartilage for the treatment of a number of maladies, including such cancers as disclosed in U.S. Pat. No. 4,822,607 and as a food supplement product. This improvement in the process of preparation is a continuation-in-part of my U.S. patent application Ser. No. 08/302,518 filed Nov. 9, 1994, now U.S. Pat. No. 5,503,990. The present improvement over the above referenced U.S. patent application, which is considerably less expensive, is accomplished by replacing the final cryogenic milling process with a new step including subjecting the processed cartilage to an ACM pulverizer mill, then to a Tenberg B cyclone, while the fine dust is collected by a fine dust bag and the cartilage powder is collected and sent to packaging and/or encapsulation.

Abstract: A pharmaceutical formulation comprising a polymeric resin having bile acid binding properties in combination with at least one bile acid binding material which enhances the bile acid binding affinity and/or capacity of the formulation, methods for preparing the formulations and methods for using the formulations.

Abstract: A slow-release pharmaceutical composition containing a bile acid as active ingredient and comprising at least one bioadhesive substance and at least one high specific gravity substance, an aliquot thereof being enteric coated and the remainder being non-enteric coated.

Abstract: The present invention relates to a significant improvement in the preparation of a pharmaceutically purified and proven effective product of powdered hormone-free bovine cartilage for the treatment of a number of different cancers, such as those disclosed in U.S. Pat. No. 4,822,607. This improvement in the process of preparation accomplishes this by producing a more effective product because the novel process produces particles of a more uniform size. The novel process is more efficient because it is less costly and less time consuming to prepare than the presently used process.

Abstract: Bile acid derivatives, processes for their preparation and use as pharmaceuticals Bile acid derivatives of the formula IW--X--Gin which G is a bile acid radical, W is an active compound moiety of a medicament and X is a bonding member between a bile acid radical and active compound moiety, are outstandingly suitable for introducing active compounds into the enterohepatic circulation. The compounds I are absorbed and pass into the bloodstream. It is possible in this way, using the natural reabsorption of the bile acids, to achieve improved absorption of non-absorbable or poorly absorbable pharmaceuticals.W may be, for example, a peptide, an antibiotic, an antiviral substance, an anticancer agent, a hepatoprotective agent, an antihyperlipidemic, a diuretic, a hypotensive, a renin inhibitor, a substance for the treatment of cirrhosis of the liver or a substance for the treatment of diabetes.

Abstract: A purified naturally occurring natriuretic compound, identified as Natriuretic Hormone, and a method for isolation of the compound. The natriuretic compound has a molecular weight of about 360, a molecular formula of C.sub.21 H.sub.28 O.sub.5 and with a steroidal nucleus. The compound is useful as a diuretic in the treatment of diseases such as heart disease and hypertension.

Abstract: A method of enhancing the ability of cattle and swine to resist diseases caused by microorganisms which comprises the steps of adding an antimicrobial effective amount in a range of 0.01 to 0.2% by weight of bile powder to a livestock feed and administering the livestock feed prepared to the cattle and swine. The method may also comprise adding a pharmaceutical effective amount of one of the following: licorice, garlic or quillaja powders or extracts thereof to the livestock feed.

Abstract: A purified naturally occurring natriuretic compound, identified as Natriuretic Hormone, and a method for isolation of the compound. The natriuretic compound has a molecular weight of about 360, a molecular formula of C.sub.21 H.sub.28 O.sub.5 and with a steroidal nucleus. The compound is useful as a diuretic in the treatment of diseases such as heart disease and hypertension.

Abstract: In accordance with practice of the process of this invention, a composition is provided which is useful as a dietary supplement. The composition, which comprises bile salts permanently complexed with insoluble cellulose, upon ingestion by a human, facilitates passage of fats through the gastrointestinal tract and out from the body.