Abstract: Methods for clarification of cell samples using centrifugation in combination with depth filtration.

Abstract: Methods and materials for making complex, living, vascularized tissues for organ and tissue replacement, especially complex and/or thick structures, such as liver tissue is provided. Tissue lamina is made in a system comprising an apparatus having (a) a first mold or polymer scaffold, a semi-permeable membrane, and a second mold or polymer scaffold, wherein the semi-permeable membrane is disposed between the first and second molds or polymer scaffolds, wherein the first and second molds or polymer scaffolds have means defining microchannels positioned toward the semi-permeable membrane, wherein the first and second molds or polymer scaffolds are fastened together; and (b) animal cells. Methods for producing complex, three-dimensional tissues or organs from tissue lamina are also provided.

Abstract: Apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells, are described. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device. The introduction of the cells may occur after a blood centrifugation product, such as platelet-poor plasma, is applied to the luminal surface. After the cells are introduced, the device is then subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward and adhere to the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient. The implantable medical device may be inserted into a protective sleeve prior to seeding the device with cells, and the sleeve may or may not be removed prior to implantation.

Abstract: A composition suitable for mammalian oral ingestion in a mammal having GI tract inflammation comprising an anti-diarrhea effective amount of glutamine, fermentable fiber(s), antioxidant(s), and omega-3 fatty acid(s).

Abstract: The present invention provides a method, and resulting product, for the removal of unwanted molecules from a host's blood using a one-step procedure. The unwanted molecules may be anti-A blood protein and/or anti-B blood protein antibodies that would otherwise cause host rejection of transplanted organs or tissues from a source having a different ABO blood type. The unwanted molecules may also be excess antibodies, or virions, present in a diseased host.

Abstract: The present invention relates to a method for constructing human skin tissue, in which human skin tissue is reconstructed on a body surface of an immunodeficient non-human animal.

Abstract: Methods and apparatuses involving biocompatible structures for tissue engineering and organ replacement and, more specifically, biocompatible structures formed by three-dimensional fabrication, are described. In some embodiments, the biocompatible structures are scaffolds for cells that can be used as tissue engineering templates and/or as artificial organs. The structures may be three-dimensional and can mimic the shapes and dimensions of tissues and/or organs, including the microarchitecture and porosities of the tissues and organs. Pores in the structure may allow delivery of molecules across the structure, and may facilitate cell migration and/or generation of connective tissue between the structure and its host environment. Structures of the invention can be implanted into a mammal and/or may be used ex vivo as bioartificial assist devices.

Abstract: Living cellular material is encapsulated or placed in a protective material (cell protector) which is biocompatible, biodegradable and has a three-dimensional form. The three dimensional form is incorporated into a matrix that maybe implanted in vivo, ultimately degrade and thereby by replaced by living cell generated material.

Abstract: Disclosed is a method of selectively inhibiting for growth of non-target cells in a mixed population of target and non-target cells, the method comprising the steps of: (a) contacting the mixed population with a selective agent which comprises a carrier moiety linked by a scissile linkage to a toxic moiety; wherein the selective agent is able to enter non-target cells in which the scissile linkage is cleaved, releasing the toxic moiety to exert a toxic effect on the non-target cells causing inhibition of the growth of the non-target cells, whereas the selective agent is unable to enter target cells and/or the scissile linkage is not cleaved in target cells and/or toxic moiety, if released from the selective agent, does not exert a toxic effect on the target cell; and (b) culturing the cells in conditions which allow for growth of non-inhibited cells.

Abstract: This invention describes unique patterns of distribution of ganglioside GM1 in non-capacitated sperm and demonstrates that the pattern of distribution of GM1 undergoes changes that can be correlated with the process of capacitation and/or with acrosomal exocytosis. Accordingly, the present invention discloses a method for determining the ability of sperm to respond to capacitation and/or acrosomal exocytosis stimuli. The method comprises determination of distribution pattern for GM1. The method can be used for both diagnostic and predictive purposes when assessing male reproductive fitness, and can also be used to assess the effects on sperm of cryoprotective agents and protocols, and contraceptive agents.

Abstract: The invention provides a method of enumerating the number of cells of a cell type in a cell sample by (a) counting the white blood cells in the cell sample to obtain the white blood cell population of the sample; (b) determining the proportion or percentage of the cells of the cell type in the white blood cell population in the sample; and (c) calculating the number of cells of the cell type in the sample. The cell type may be a lymphocyte sub-set selected from the group comprising CD4+ lymphocytes, CD 45 cells, CD19 cells, CD16 and CD56 positive cells, CD8 cells, CD3 cells or any combination thereof. The method is particularly useful in monitoring the immune status of a patient infected with HIV or other immune deficiency state or disease or condition where CD4+ lymphocytes or CD4+ T cells are monitored or counted.

Abstract: This invention provides an antigen-free and immunologically inert tissue graft material and methods of preparing and using these tissue graft materials.

Abstract: Bone graft substitute compositions and methods of making the compositions are disclosed. In some embodiments, a method of making a composition includes contacting a mixing solution with a first mixture having calcium sulfate hemihydrate and a plasticizing material to form a second mixture; waiting a predetermined period of time after forming said second mixture; and then contacting demineralized bone with the second mixture to form the composition. A composition can be formed from a kit including a first mixture having calcium sulfate hemihydrate and a plasticizing substance, a second mixture having demineralized bone, and a mixing solution. The first and second mixtures and the mixing solution are unblended.

Abstract: The present invention is directed to methods for readily propagating somatic hair follicle stem cells or melanocyte stem cells. The methods comprise enhancing guanine nucleotide (GNP) biosynthesis, thereby expanding guanine nucleotide pools. This in turn conditionally suppresses asymmetric cell kinetics in the explanted cells. The methods of the invention include pharmacological methods and genetic methods. For example, the resulting cultured somatic hair follicle stem cells can be used for a variety of applications including cell replacement therapies such as hair transplants, gene therapies, and tissue engineering applications, such as the generation of artificial skin and skin regeneration strategies including skin grafts.

Abstract: To provide a microorganism and an ingredient thereof that contribute to prevention and treatment of immune diseases including allergy, autoimmune diseases and inflammatory bowel diseases (e.g., large-intestinal ulcer), a method of effectively selecting the microorganism, and a method of efficiently inducing immunoregulatory cells that play an important role on maintaining immunological homeostasis using the microorganism or the ingredient thereof.

Abstract: Microvessel networks are produced in vitro from tissue-engineered parent vessels sprouting into a supporting matrix, as for example gels, of extracellular matrix proteins. The microvessel systems are integrated into devices that allow for controlled perfusion with fluids. The vessels may include cells from one cell type, for example, endothelial cells, or from combinations of two or more cell types.

Abstract: A bone graft material comprising about 50-90% quickly bioresorbable porogen particles and about 10-50% of a calcium matrix material. A bioactive substance can be included in the matrix material, the porogen particles, or both. Commercial packages containing the bone graft materials and methods for repairing bone therewith are also claimed.

Abstract: In one aspect, the invention provides methods for forming a target tissue substitute. The methods of the invention comprise the following steps: (a) providing a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is designed to mimic the configuration of one or more structural elements in a target tissue; and (b) culturing cells on the scaffold to form a target tissue substitute. In another aspect, the invention provides implantable medical devices. The implantable medical devices of the invention comprise a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is arranged to mimic the configuration of one or more structural elements in a target tissue. Typically, cells are cultured on the scaffold to form a target tissue substitute.

Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Abstract: A vaginal treatment composition that employs a therapeutic agent to inhibit and/or treat vaginal infection is provided. The therapeutic agent is capable of inhibiting and/or killing Gardnerella (e.g., Gardnerella vaginalis), Candida (e.g., Candida albicans), and/or Trichomonas (e.g., Trichomonas vaginalis) pathogens. Desirably, such antimicrobial efficacy is achieved without substantially inhibiting the growth of Lactobacillus acidophilus. For instance, sugars and/or sugar alcohols may be employed in the present invention as a therapeutic agent for inhibiting and/or treating vaginal infection. In one particular embodiment, D-xylitol is used as the therapeutic agent.