Abstract: The present invention relates to a composition comprising an isolated CD4+ Treg cell population, wherein the Treg cells have signatures for i) identifying that the T-cells are CD4+ regulatory Tcells, ii) identifying that the Treg cells are tissue type tropic, i.e they can migrate to the diseased tissue, iii) optionally identifying that the Treg cells are tropic with respect to the diseased tissue, i.e. they are homing cells, iv) identifying that the Treg cells are emigrant cells, i.e. they originate from the target tissue, and v) optionally identifying that the Treg cells are retained in the target tissue and optionally one or more X-signatures and/or one or more Y-signatures and one ore more Z-signatures.

Abstract: This invention relates to compounds of Formula I: (Formula I), and pharmaceutically acceptable salt thereof, which are allosteric effectors that increase the oxygen-being affinity of hemoglobin, which are useful in the treatment of sickle cell disease, high altitude tissue hypoxia, and other conditions.

Abstract: The invention provides methods for treating pathological conditions associated with an undesirable inflammatory component. The invention is generally directed to reducing inflammation by administering cells that have one or more of the following effects in an injured subject: interact with splenocytes, preserve splenic mass, increase proliferation of CD4+ and CD8+ T-cells, increase IL-4 and IL-10, decrease IL-6 and IL-1?, and increase M2:M1 macrophage ratio at the site of injury. The invention is also directed to drug discovery methods to screen for agents that modulate the ability of the cells to have these effects. The invention is also directed to cell banks that can be used to provide cells for administration to a subject, the banks comprising cells having desired potency for achieving these effects.

Abstract: The present application provides methods and processes for making and using a mesenchymal stem cell secretome, as well as methods for treating ocular conditions and/disorders with the mesenchymal stem cell secretome described herein.

Abstract: The present invention relates to substantially homogenous populations of human retinal progenitor cells having the following positive surface markers: SSEA4, CD73, PTK7 and PSA-NCAM. The invention also relates to method for preparing such substantially homogeneous cell populations from human tissue using cell sorting techniques.

Abstract: The present invention is directed to a device for enriching cells with a cell surface marker, comprising an aptamer suitable for specifically binding the cell surface marker, and beads coupled thereto, wherein the aptamer is coupled to the beads in a manner that allows for release of cells expressing the cell surface marker, in the absence of a chemical agent, and production of a cell population enriched for cells expressing the cell surface marker, substantially free of beads and aptamer. Kits comprising the device or components thereof, and methods of cell enrichment, are also provided. In exemplary embodiments, the device contains an aptamer that specifically binds CD31.

Abstract: Cell-based therapies for cartilage repair and regeneration selectively using chondrocytes carrying a CD24 surface marker are disclosed. In particular, chondrocytes carrying the CD24 surface marker have a high regenerative potential and low responsiveness to inflammatory cues. Since cartilage injuries as well as chronic cartilage degenerative conditions are often accompanied by a heightened inflammatory environment, cartilage cell populations carrying the CD24 surface marker, which are resistant to the inflammatory environment, provide more efficient cartilage repair. Thus, chondrocytes carrying the CD24 surface marker are useful in cell-based therapies for regenerating or repairing cartilage.

Abstract: Provided herein are novel methods and composition utilizing adipose tissue-derived stromal stem cells for treating fistulae.

Abstract: Cells derived from postpartum tissue and products thereof having the potential to support cells of and/or differentiate to cells of a soft tissue lineage, and methods of preparation and use of those postpartum tissue-derived cells, are provided by the invention. The invention also provides methods for the use of such postpartum-derived cells and products related thereto in therapies for conditions of soft tissue.

Abstract: The present invention is directed to compositions comprising a mixture of microbes and the metabolites produced when the microbes are grown together. The invention is further directed to methods for making and using the compositions.

Abstract: Formulations and methods for treating inflammation using pitcher plants. The pitcher plant is made into herbal preparations, such as tinctures and infused solutions. The herbal preparation of the pitcher plant is combined with glutathione, solutions, supplements, or other plant preparations to make a composition. Administering the composition to a subject can reduce inflammation, increase fibroblast growth factors, and adjust fibrinogen to homeostatic levels, thereby treating the inflammation.

Abstract: Described herein, inter alia, are processes, methods, and compositions useful for the extraction of natural products from source materials.

Abstract: The present disclosure discloses a natural pharmaceutical composition for treating osteoporotic fracture and/or osteoarthritis and an application thereof. The composition is composed of 73.3 wt %-98.3 wt % of sea buckthorn pulp oil and 1.7 wt %-26.7 wt % of panax notoginseng saponins. The composition can be further used for preventing and treating ostealgia diseases.

Abstract: Methods of treating colorectal cancer using water extracts derived from dittrichia viscosa leaves are provided.

Abstract: A method and formulation for delivering an active analgesic compound, such as an opiate, in a vaporized state using low temperatures to vaporize the formulation. The formulation contains an inert non-reactive compound that lowers the heat of vaporization of the formulation, and the active compound. The formulation may optionally contain glycerin, alcohol, and/or water. Examples of inert non-reactive compounds that can sufficiently lower the heat of vaporization of the formulation include propylene glycol, vegetable glycerin and polysorbate. The formulation can be vaporized using a hand-held low temperature vaporizer or atomizer.

Abstract: A so-called molecular-targeted drug acting on a signal transduction pathway in a cell has been developed. However, a side effect of the molecular-targeted drug is not negligible for a patient. Thus, there has been a demand for a substance that exhibits a significant growth inhibitory effect on a cancer cell with fewer side effects as a health food and a pharmaceutical composition. It has been found that a hexane extract fraction of a watermelon sprout has an effect of specifically inhibiting the cell growth of the cancer cell and such an effect is primarily caused by phytol and lutein. A processed food and pharmaceutical composition having these substances as main components can exert an anticancer action without causing side effects.

Abstract: The present invention provides a topical formulation comprising an active agent, which comprises salvigenin and optionally asiaticoside. The present invention also relates to the use of the topical formulation for the promotion of wound healing.

Abstract: Disclosed is a composition comprising an beautyberry total glycosides extract, and a method of preparation thereof, and the use of the composition thereof in preparing drugs for treating neurodegenerative diseases or skin diseases. The extract thereof is prepared from the leaves of Callicarpa cathayana H.T. Chang or Callicarpa formosana Rolfe, and contains 18% to 45% verbascoside and 15% to 40% Arenarioside.

Abstract: A composition with a health preserving effect, comprising 2.5-6.5 parts of Rhizoma Polygonati and 27.5-84.5 parts of a Rhizoma Polygonati-soaked solution mixture. The Rhizoma Polygonati-soaked solution mixture is a mixture of a baijiu soaking solution obtained by soaking Rhizoma Polygonati in baijiu and dregs of a decoction. Also provided are health preserving wine prepared from the composition and a preparation method thereof. The preparation method comprises subjecting the Rhizoma Polygonati and the Rhizoma Polygonati-soaked solution mixture to mixed culture fermentation with proso millet. The health preserving wine is prepared by combining fermentation and soaking processes.

Abstract: The present invention relates to formulations containing a combination of extracts from Curcuma longa, Punica granatum and Zingiber officinale, acting synergistically in the treatment and prevention of disorders of the mouth, throat and respiratory tract; the formulation is especially active on disorders of bacterial origin, e.g. those occurring in patients affected by common cold and flu and their complications. The present formulations are particularly useful in the reduction of incidence of sores throat and their infections and in the elimination of antibiotic use, especially among infants and the elderly.

Abstract: The present invention relates to series of compounds as an inhibitor targeting Proliferating Cell Nuclear Antigen (PCNA). Pharmaceutical compositions of those compounds and methods of using them in the treatment of cancer are within the scope of this disclosure.

Abstract: The present invention provides lyophilized formulations of active agents, particularly of TAT-NR2B9c, as chloride salts. TAT-NR2B9c has shown promise for treating stroke, aneurysm, subarachnoid hemorrhage and other neurological or neurotraumatic conditions. The chloride salt of TAT-NR2B9c shows improved stability compared with the acetate salt form of prior formulations. Formulations of the chloride salt of TAT-NR2B9c are stable at ambient temperature thus facilitating maintenance of supplies of such a formulation in ambulances for administration at the scene of illness or accident or in transit to a hospital.

Abstract: The invention relates to methods of using variants and fusions of fibroblast growth factor 19 (FGF19) for treating diabetes.

Abstract: Clostridium difficile infection is the leading cause of hospital acquired antibiotic-associated diarrhea in the US (Bartlett, in 2006). The increased prevalence of circulating C. difficile strains poses a significant health threat to US health care facilities. Strains expressing the toxin C. difficile Transferase (CDT), in addition to Toxins A and B (TcdA and TcdB), are more virulent and are associated with higher mortality rates (Bacci et al., 2011). We recently identified a protective role for eosinophils against C. difficile pathogenesis (Buonomo et al., 2016). We have also defined CDT's ability to increase host inflammation and suppress protective eosinophils through a TLR2 dependent mechanism (Cowardin et al., 2016). How CDT promotes virulence and eosinophil suppression via TLR2 is still under investigation.

Abstract: The present invention relates to exendin-4 derivatives and their medical use, for example in the treatment of disorders of the metabolic syndrome, including diabetes and obesity, as well as reduction of excess food intake.

Abstract: The invention provides a method for treating a condition in which growth hormone administration is beneficial, for treating osteoarthritis, for increasing chondrocyte, proteoglycan or collagen production or quality or repair or promoting cartilage tissue formation or repair, for promoting or improving muscle, ligament or tendon mass, repair, form or function, or for treating inflammatory, traumatic or genetic diseases of muscle or connective tissue, comprising administering to a subject an effective amount of a peptide comprising a carboxyl-terminal sequence from a growth hormone and not the IGF-1 domain of growth hormone. It also provides a method of treating a condition involving insufficient functional chondrocytes or insufficient functional cartilage tissue, the method comprising administering to a subject in need thereof a peptide comprising a carboxyl-terminal sequence from a growth hormone and not the domain of growth hormone responsible for IGF-1 production.

Abstract: Devices for guided tissue regeneration (GTR) include a matrix of chitosan and mutable collagenous tissue (MCT) wherein the chitosan is electrostatically bonded to the MCT to form MCT-chitosan composite material. The MCT can be isolated from invertebrate marine organisms, such as sponges, jellyfish, mollusks and echinoderms. The MCT-chitosan composite material can be formulated as a biofilm, a 3D-sponge, a hydrogel, or as an electrospun nanofiber, or the MCT-chitosan composite material can coat a biomaterial surface. The devices can include wound dressings and tissue sponges, including 3D sponges. Applications include tissue engineering and wound healing, as well as burns and other related guided tissue regeneration applications. MCT and MCT-chitosan composite material, contained in a pharmaceutically acceptable topical carrier, also has cosmeceutical applications, for treating scars, as well as skin discoloration and various pigmentation issues, including melasma/chloasma.

Abstract: Disclosed are recombinant meganucleases engineered to recognize and cleave recognition sequences present in a mutant RHO P23H allele. The invention further relates to the use of such recombinant meganucleases in methods for treating retinitis pigmentosa, wherein the mutant RHO P23H allele is preferentially targeted, cleaved, and inactivated.

Abstract: Compositions and methods to treat biofilms are disclosed based on the discovery of the role of the disaccharide trehalose in microbial biofilm development. In various embodiments to treat body-borne biofilms systemically and locally, the method includes administering trehalase, the enzyme which degrades trehalose, in combination with other saccharidases for an exposition time sufficient to adequately degrade the biofilm gel matrix at the site of the biofilm. The method also includes administering a combination of other enzymes such as proteolytic, fibrinolytic, and lipolytic enzymes to break down proteins and lipids present in the biofilm, and administering antimicrobials for the specific type(s) of infectious pathogen(s) underlying the biofilm. Additionally, methods are disclosed to address degradation of biofilms on medical device surfaces and biofilms present in industrial settings.

Abstract: The present invention relates to a novel polypeptide which displays IgG cysteine protease activity, and in vivo and ex vivo uses thereof. Uses of the polypeptide include methods for the prevention or treatment of diseases and conditions mediated by IgG, and methods for the analysis of IgG.

Abstract: Formulations comprising recombinant human tripeptidyl peptidase-1 (rhTPP1) for intrathecal, intracerebroventricular, or intraocular administration, and kits comprising the same, are disclosed. Methods of using rhTPP1 in the prevention and treatment of symptoms of Neuronal Ceroid Lipofuscinosis (CLN2) disease are also disclosed. The formulations and methods are effective in halting the progression of CLN2 disease and may be used to treat subjects having CLN2 or a family history of CLN2.

Abstract: The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.

Abstract: The present disclosure provides immunogenic materials and methods useful for reducing the risk of fungal infections, particularly valley fever. The disclosure also provides assays for identifying compounds useful to treat valley fever, as well as methods for ameliorating the symptoms of valley fever.

Abstract: The present invention relates to the fields of veterinary parasitology and -vaccinology; more specifically the invention relates to a composition comprising live Eimeria oocysts and a pharmaceutically acceptable carrier. The composition is characterised in that it comprises a TLR3 agonist. The composition can be used to prepare a vaccine for poultry against Coccidiosis. The vaccine can be applied for example as a coarse spray on day-old chicks. The TLR3 agonist in the vaccine allows for a reduction of the dose of Eimeria oocysts up to 4 fold, while obtaining the same level of protection against challenge as from a vaccine without the TLR3 agonist. Alternatively, when employing a conventional dose of Eimeria oocysts in the vaccine, the TLR3 agonist causes an earlier onset of immunity, resulting in a significant reduction of the intestinal lesion score upon challenge, already at 2 instead of at 3 weeks after vaccination.

Abstract: The present invention relates to an immunogenic composition comprising: a) one or more antigen of M. hyorhinis and one or more antigens of M. hyosynoviae; and b) a pharmaceutically acceptable carrier. Furthermore, the present invention relates to an immunogenic composition that comprises a) one or more mycoplasma antigens of mycoplasma bacteria selected from the group consisting of M. hyorhinis, M. hyopneumoniae and M. hyosynoviae; and b) one or more components of a eukaryotic cell system. Moreover, the present invention also provides an immunogenic composition obtained by a method comprising a) cultivation of a mycoplasma bacteria selected from the group consisting of M. hyorhinis, M. hyopneumoniae and M. hyosynoviae in a serum-reduced, eukaryotic cell system; b) obtaining an antigen of such mycoplasma bacteria; and c) addition of a pharmaceutically acceptable carrier.

Abstract: Disclosed is a composition for preventing and treating a Mycoplasma hyorhinis infection in swine. The composition uses XylF, DnaK, P72, or a combination thereof as an active pharmaceutical ingredient. Further disclosed are an expression vector and a method for producing the active pharmaceutical ingredient of the composition using a prokaryotic expression system.

Abstract: Disclosed are stable conjugate vaccine formulations for protection against Salmonella typhi, and methods of conjugation between Vi-polysaccharide of S. typhi to tetanus toxoid as the carrier protein, responsible for producing improved T-dependent immune response against Typhoid fever caused by Salmonella typhi. The methods disclosed in this invention and the resulting formulations are capable of inducing immunity against typhoid fever including in children below 2 years of age, through only a single injection to comprise a complete vaccination schedule.

Abstract: Protein complex variants, compositions, and methods of use thereof are provided. The protein complex variant includes a cholera toxin B subunit variant having one or more modifications thereto. The method of use thereof includes treating a disease by administering an effective amount of a composition including a cholera toxin B subunit variant to a subject in need thereof.

Abstract: The invention is directed to compositions and methods for the stabilization of viral and bacterial vaccines. Vaccines of the invention are contained in VLPs with stabilizing agents such as, for example, sugar alcohols (e.g., sorbitol) and degraded gelatins. Preferably the gelatin has an average molecular weight of 10,000 kilodaltons or less. These vaccines have a substantially improved thermostability as well as long term stability. The invention is also directed to the manufacture of a vaccine or the invention and methods for the administration of a vaccine of the invention to patients.

Abstract: Embodiments disclosed herein provide compositions, methods, and uses for respiratory syncytial viruses (RSV) and immunogenic compositions thereof. Certain embodiments provide RSV having cleavage-resistant mutated attachment (G) glycoproteins. In some embodiments, the cleavage-resistant G protein mutants increase production of live attenuated RSV in host cells. Also provided are methods for amplifying RSV in host cells, wherein the amplified RSV has full length G protein. In certain embodiments, the amplified RSV having full length G protein is formulated into immunogenic compositions, including vaccines. Other embodiments provide methods for inducing an effective immune response against RSV infection in a subject.

Abstract: A recombinant vaccine comprising a serotype 9 fowl adenovirus vector (FAdV-9) having at least one exogenous nucleotide sequence inserted encoding at least one antigen of a disease of interest and replacing the adenovirus genome non-essential region, and a pharmaceutically acceptable vehicle, adjuvant and/or excipient, wherein the at least one exogenous nucleotide sequence encoding at least one antigen of a disease of interest and replacing the adenovirus genome non-essential region is located between the 491 and 2782 nucleotides. The vector of this vaccine is stable for industrial scale production. When administering this vaccine in combination with a vaccine against Marek's disease, both vaccines produce an adequate immune response which is not affected by interference between each other. In the same way, effectiveness of the recombinant vaccine is not affected by maternal antibodies, and is capable of inducing both an early and lasting protective response, even with only one application.

Abstract: The subject invention concerns methods and materials for inducing an immune response in an animal or person against an immunodeficiency virus, such as HIV, SIV, or FIV. In one embodiment, a method of the invention comprises administering one or more antigens and/or immunogens to the person or animal wherein the antigen and/or immunogen comprises one or more evolutionarily conserved epitopes of immunodeficiency viruses. In one embodiment, the epitope is one that is conserved between HIV and FIV.

Abstract: The present application relates to a method for desensitization of allergic patients. More specifically it relates to an epicutaneous desensitization method, applicable to any type of allergens and of patients. The method of the invention is essentially non-invasive and does not require the use of adjuvants. Further, it may be easily applied and monitored by the actual patient.

Abstract: Compositions and methods for co-expressing a secretable vaccine protein (such as gp96-Ig) and T-cell co-stimulatory molecules from a single vector, among others, are provided herein. Materials and methods for using gp96-Ig vaccination and T-cell co-stimulation to treat a clinical condition (e.g., cancer) in a subject also are provided.

Abstract: The present disclosure relates to antibodies specific tumor associated complex N-glycans with terminal GlcNAc? residues and methods for detecting a tumor in a subject. The present disclosure also relates to therapeutic antibodies specific for tumor associated complex N-glycans with terminal GlcNAc? residues.

Abstract: The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of an agent selected from an anti-metabolite agent or analog thereof and combinations thereof; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided herein.

Abstract: The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of a topoisomerase inhibitor; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided herein.

Abstract: The present disclosure relates to human monoclonal antibodies against orexin receptor type 1 (OX1R, hyprocretin 1) and uses thereof for the treatment of cancer. The antibodies are characterized by their CDRs: NYYMN, YISGSSRNIYYADFVKG, SNYDGMDV (Heavy chain) and AGTSSDVGGSNYVS, PGKAP, SSYTYYSTRV (Light Chain)) or the CDRS having at least 50% or 70% identity with the above listed sequences.

Abstract: Provided herein are ready-to-use premixed pharmaceutical compositions of nicardipine or a pharmaceutically acceptable salt and methods for use in treating cardiovascular and cerebrovascular conditions.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.