Abstract: The presently disclosed subject matter provides a scalable and electrostretching approach for generating hydrogel microfibers exhibiting uniaxial alignment from aqueous polymer solutions. Such hydrogel microfibers can be generated from a variety of water-soluble natural polymers or synthetic polymers. The hydrogel microfibers can be used for controlled release of bioactive agents. The internal uniaxial alignment exhibited by the presently disclosed hydrogel fibers provides improved mechanical properties to hydrogel microfibers, and contact guidance cues and induces alignment for cells seeded on or within the hydrogel microfibers.

Abstract: The presently disclosed composition and methods are provided for a hydrogel or nanofiber-hydrogel composite integrated with a surgical scaffold or mesh. A surgical scaffold device comprised of laminar composite is disclosed for the purpose of reducing foreign body response, managing tissue-materials interface, and improving the integration of the surgical mesh with the surrounding tissue of a subject.

Abstract: An improved skin substitute is presented comprised of a silicone layer backed up with a woven nylon fabric layer, the silicone layer possessing a regular pattern of slits that permit the porosity of the skin substitute to be adjusted by clinicians by means of applying tension to the skin substitute that differentially opens the slits. A variety of therapeutic substances can be applied to the skin substitute to promote healing, including aloe and other medicinal preparations. A layer of water soluble or water insoluble anti-scar compound is also present, the preferred compound being salinomycin.

Abstract: A post-surgical healing accelerator (PSHA) device for tissue and nerve repair at an injury site. The device includes (a) a substrate, (b) a scaffold disposed on a surface of the substrate, and (c) a population of cells attached to the scaffold. The scaffold comprises at least one modified polymer selected from a modified collagen, a modified gelatin, a modified alginate, a modified cellulose, a modified hyaluronic acid, and others, with (i) modifications configured to increase an interaction between the scaffold and the cells, (ii) modifications configured to increase an association of the at least one modified polymer with the substrate, and (iii) a combination of (i) and (ii). The cells attached to the scaffold are configured to carry out tissue and/or nerve repair at an injury site of a subject through at least one of growth, differentiation, and migration following an application of the device to the injury site of the subject.

Abstract: An anti-adhesion material comprising decellularized tissues and a biocompatible polymer or fibrin glue; a method for preparing an anti-adhesion material comprising complexing a biocompatible polymer or fibrin glue to decellularized tissues; an anti-adhesion material kit comprising decellularized tissues and a biocompatible polymer or fibrin glue; a substitute biomembrane comprising decellularized tissues and a biocompatible polymer or fibrin glue; a method for preparing a substitute biomembrane comprising complexing a biocompatible polymer or fibrin glue to decellularized tissues; and a substitute biomembrane kit comprising decellularized tissues and a biocompatible polymer or fibrin glue.

Abstract: A composite implant device for use in a medical application, comprising a synthetically-derived mesh that mimics particular critical aspects of a biologically-derived mesh. The composite implant device can be used for the reinforcement and reconstruction of tissues within the body and can be comprised of a majority of synthetic components and minority of naturally-derived components which mimic the structure and function of a naturally-derived mesh.

Abstract: A construct that supports cell attachment and alignment including a substrate that is incompatible with photolithography conditions, containing a physical pattern in at least part of one surface, the physical pattern optionally bearing a coating of a metal alkoxide, oxide or mixed oxide-alkoxide thereon and a Self-Assembled Monolayer of Phosphonate (SAMP) covalently attached thereto, which phosphonate contains functionality adapted for cell binding. The construct optionally also contains cells attached thereto. Also disclosed are methods of preparing such a construct.

Abstract: Provided herein are bioactivated polymer/extracellular matrix (ECM) composites and methods of preparation and use thereof. In particular, heparinized cysteine-polymer/ECM composites, and methods of preparation and use thereof, are provided. In some embodiments, provided herein are compositions comprising a composite of: (a) extracellular matrix (ECM), and (b) a polyester covalently linked to a bioactive agent. In some embodiments, the composite is a homogeneous composite. In some embodiments, the ECM is decellularized ECM. In some embodiments, the ECM is not substantially crosslinked.

Abstract: An improved skin substitute is presented comprised of a silicone layer backed up with a woven nylon fabric layer, the silicone layer possessing a regular pattern of slits that permit the porosity of the skin substitute to be adjusted by clinicians by means of applying tension to the skin substitute that differentially opens the slits. A variety of therapeutic substances can be applied to the skin substitute to promote healing, including aloe and other medicinal preparations. The skin substitute is directed at chronic wound treatment and hernia repair.

Abstract: Methods for producing compositions of decellularized extracellular matrix (DM) tissue culture are described. The compositions can be used for coating supports such as tissue culture substrates, osteogenic gels, and medical devices.

Abstract: An artificial blood vessel that can be transplanted to blood vessels with a small diameter, can be adjusted to an arbitrary size of a diameter, improves in invasiveness when a graft is taken, and overcomes the problem on the provision of a graft is provided. An artificial blood vessel prepared from a decellularized tubular structure, which is prepared by processing a decellularized, sheet-like blood vessel (decellularized blood vessel sheet) into a roll structure, and a tissue adhesive, wherein a portion which is contacted with blood that flows within the artificial blood vessel consists of the tissue of the tunica intima lined with the tissue of the tunica media whereas a portion of the sheet that overlaps when the sheet is processed into a roll structure (overlap width) consists of the tissue of the tunica media and wherein a tissue adhesive is applied to the overlap width.

Abstract: It is provided a blood vessel function inspecting apparatus including: a blood vessel diameter measuring portion configured to measure a diameter of a blood vessel; a blood vessel wall thickness measuring portion configured to measure a wall thickness of the blood vessel; and a blood vessel function index value calculating portion configured to calculate a function index value for diagnosing the blood vessel of its function, after releasing of the blood vessel from blood flow obstruction, by dividing an amount of dilatation of said diameter of the blood vessel continuously measured by said blood vessel diameter measuring portion, by the wall thickness measured by said blood vessel wall thickness measuring portion.

Abstract: Vascular grafts for treating, reconstructing and replacing damaged or diseased cardiovascular vessels that are formed from decellularized extracellular matrix (ECM). The vascular grafts include outer or outer and inner coatings that provide structural reinforcement.

Abstract: A removable sleeve extends around an expandable stent graft to constrain the expandable stent graft toward a collapsed configuration. The sleeve is held together by a coupling member to constrain the expandable device toward the collapsed configuration for endoluminal delivery to a vascular treatment site. The sleeve is openable by displacing the coupling member away from the sleeve to allow outward expansion of the expandable device toward an expanded configuration. The sleeve is separate from the expandable device so as to be removable from the treatment site after deployment of the expandable device.

Abstract: An improved skin substitute is presented comprised of a silicone layer backed up with a woven nylon fabric layer, the silicone layer possessing a regular pattern of slits that permit the porosity of the skin substitute to be adjusted by clinicians by means of applying tension to the skin substitute that differentially opens the slits. A variety of therapeutic substances can be applied to the skin substitute to promote healing, including aloe and other medicinal preparations. A layer of water soluble or water insoluble anti-scar compound is also present, the preferred compound being salinomycin.

Abstract: Mufti-sheet laminate structures having a first extracellular matrix (ECM) sheet member having a top cross-linked surface and a second ECM sheet member having a bottom surface, the second ECM sheet member being joined to the first ECM sheet member, wherein the first ECM sheet member top cross-linked surface is disposed proximate the second ECM sheet member bottom surface.

Abstract: A synthetic construct suitable for implantation into a biological organism that includes at least one polymer scaffold; wherein the at least one polymer scaffold includes at least one layer of polymer fibers that have been deposited by electrospinning; wherein the orientation of the fibers in the at least one polymer scaffold relative to one another is generally parallel, random, or both; and wherein the at least one polymer scaffold has been adapted to function as at least one of a substantially two-dimensional implantable structure and a substantially three-dimensional implantable tubular structure.

Abstract: Methods for ameliorating stent graft migration and endoleak using treatment site-specific cell growth promoting compositions in combination with stent grafts are disclosed. Also disclosed are application of cell growth promoting compositions such as, but not limited to, autologous platelet gel compositions directly to treatment sites during or after stent graft implantation.

Abstract: The present invention provides constructs including a tubular biodegradable polyglycolic acid scaffold, wherein the scaffold may be coated with extracellular matrix proteins and substantially acellular. The constructs can be utilized as an arteriovenous graft, a coronary graft, a peripheral artery bypass conduit, or a urinary conduit. The present invention also provides methods of producing such constructs.

Abstract: Disclosed are endovascular stents in which a portion of the stents have a bioactive coating for promoting repair of damaged vessels, systems comprising the stents, and methods of using the stents to promote occlusion of aneurysms and/or repair damaged vessels.

Abstract: A vascular prosthesis comprising a tubular shaped expandable ECM member and at least one anchoring mechanism. In one embodiment, the anchoring mechanism comprises proximal and distal single or dual-ring anchors. In one embodiment, the anchoring mechanism comprises a multiple-ring anchor. The anchors preferably comprise a biodegradable metal, such as magnesium. The anchors can also comprise a shape memory alloy, such as nitinol, and a cross-linked ECM material. In some embodiments, the ECM member includes a pharmacological agent.

Abstract: Compositions and methods are provided for modulating the growth, development and repair of bone, cartilage or other connective tissue. Devices and stimulus waveforms are provided to differentially modulate the behavior of osteoblasts, chondrocytes and other connective tissue cells to promote proliferation, differentiation, matrix formation or mineralization for in vitro or in vivo applications. Continuous-mode and pulse-burst-mode stimulation of cells with charge-balanced signals may be used. Bone, cartilage and other connective tissue growth is stimulated in part by nitric oxide release through electrical stimulation and may be modulated through co-administration of NO donors and NO synthase inhibitors. Bone, cartilage and other connective tissue growth is stimulated in part by release of BMP-2 and BMP-7 in response to electrical stimulation to promote differentiation of cells.

Abstract: An extracellular matrix (ECM) construct having a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of first ECM material disposed on the top surface of the support scaffold.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: Implant provided with a coating, with the implant being provided with an amino-functionalized parylene coating, an oligonucleotide and/or an oligopeptide having a specific bonding affinity with CD34-positive cells.

Abstract: An implantable medical device having enhanced endothelial migration features, generally comprises: a structural member including a leading edge and a trailing edge interconnected by a third surface region, the leading edge including a second surface region in a generally curvilinear cross-section, and the trailing edge including a fourth surface region in a generally curvilinear cross-section, whereby blood flow over the second surface region generate shear stress at the second surface region without an eddy region in the second surface region.

Abstract: Described herein are engineered multilayered vascular tubes comprising at least one layer of differentiated adult fibroblasts, at least one layer of differentiated adult smooth muscle cells, wherein any layer further comprises differentiated adult endothelial cells, wherein said tubes have the following features: (a) a ratio of endothelial cells to smooth muscle cells of about 1:99 to about 45:55; (b) the tube is compliant; (c) the internal diameter of the tube is about 6 mm or smaller; (d) the length of the tube is up to about 30 cm; and (e) the thickness of the tube is substantially uniform along a region of the tube; provided that the engineered multilayered vascular tube is free of any pre-formed scaffold. Also described herein are methods of forming said tubes and uses for said tubes including methods for treating patients, comprising providing such a tube into to a patient in need thereof.

Abstract: An apparatus and method to treat vulnerable plaque. In one embodiment, the apparatus has a medical device to treat an occlusive plaque, and is also adapted to release a biologically active agent to treat vulnerable plaque located downstream from the occlusive plaque. In an alternative embodiment, the apparatus has an expandable tube attached to the inner surface of a stent, and a layer of endothelial cells seeded on the inner surface of the expandable tube. The expandable tube shields a vulnerable plaque from a body lumen.

Abstract: Exemplary embodiments of the present disclosure provide for multi-layered implantation materials, methods of making a multi-layered implantation material, methods of forming a multi-layered implantation material, methods of forming a multi-layered implantation material having a spiral roll cross-section, and the like.

Abstract: The invention relates to scaffolds for artificial heart valves and vascular structures comprising a biocompatible block copolymer. A method and means for producing said scaffold are also provided.

Abstract: The invention is directed to methods for preparing artificial blood vessels by preconditioning a matrix seeded with endothelial cells to fluid flow conditions that mimic blood flow.

Abstract: Described herein are modified gelatins or the pharmaceutically-acceptable salts or esters thereof comprising at least one actinically crosslinkable group covalently bonded to gelatin. The modified gelatins are useful in producing composites that ultimately can be used to produce three-dimensional engineered biological constructs. The composites are the polymerization product between the modified gelatin and at least one actinically crosslinkable macromolecule. Methods for making the modified gelatins are also described herein.

Abstract: A modified polyurethane including a lipid substituent pendant from at least one urethane nitrogen and/or at least one carbon atom of the modified polyurethane, methods of preparing modified polyurethanes and the use thereof as an implantable biomaterial.

Abstract: Embodiments of the present invention provide a composition comprising perivascular stem cells or induced pluripotent cells (iPS) and a NELL-1 factor for cardiac or vascular regeneration and methods of making and using the same.

Abstract: Tissue engineering methods and biochamber apparatus are provided for making tissue grafts for implantation into a patient. The methods include applying a sustained low magnitude pressure gradient transmurally across a permeable scaffold material using a media containing cells, preferably microvascular epithelial cells, to be deposited on the scaffold for the production of tissue grafts, preferably vascular grafts, to promote accelerated adhesion and maturation of cells on the scaffold material. Biochambers for preparing tubular tissue grafts are provided which contain connectors for holding a graft substrate, proximal and distal tubing for connection to an optional perfusion system, and structure for switching between transmural flow of a cell suspension across the graft substrate and translumenal flow through the lumen of the graft.

Abstract: A method including combining a cellular component with a viability enhancer material wherein the combination will inhibit an interaction between the cellular component and a delivery device; and delivering the cellular component through the delivery device. An apparatus including a delivery cannula having dimensions suitable for percutaneous delivery and a lumen therethrough, wherein a portion of a luminal surface of the cannula includes a coating that is amenable to a cellular component delivered through the delivery cannula. A method including percutaneously introducing a delivery cannula into a blood vessel; advancing a distal portion of the delivery cannula to a treatment site; and delivering a cellular component through a lumen of the delivery cannula, wherein a portion of a luminal surface of the cannula includes a coating that is amenable to a cellular component delivered through the delivery cannula.

Abstract: Described herein are devices and methods fabricating devices having nanostructures that allow adhesion or growth of one cell type, such as endothelial cells, more than another cell type, such as smooth muscle cells. In particular, stent covers having such nanostructures are described, and methods for fabricating these stent covers. Also described herein are methods for optimizing the nanostructures forming the devices.

Abstract: The present invention encompasses methods and apparatus for minimizing the risks inherent in endovascular grafting for blood vessel therapy and repair. The invention involves delivering adult stem cells, embryonic stem cells, progenitor cells, fibroblasts, or smooth muscle cells to the diseased blood vessel, in some embodiments in conjunction with a stent graft.

Abstract: A composite stent and a method for making the same are provided.

Abstract: Disclosed herein are implantable medical device, and in particular, vascular stent having a biocompatible scaffold seeded with endothelial cells. The stent can provide structural support to maintain the openness of a vessel lumen following angioplasty while the biological scaffold seeded with endothelial cells can provide a new, healthy blood vessel wall.

Abstract: A vascular prosthesis having a tubular structure is provided. The tubular structure is fabricated from at least two layers wherein at least one layer includes a thrombogenic agent.

Abstract: The present relates to artificial vascular grafts and for methods for performing hemodialysis with the same. The grafts comprise an inner surface on which cells genetically altered to express or over-express one or more cell adhesion factors, such as fibulin-5, or one or more cell adhesion factors and one or more cell proliferation growth factors, such as VEGF, are seeded and cultured.

Abstract: A cellular stent carries living therapeutic cellular material for implantation into a human or animal body and allows either localized or systemic delivery of the therapeutic products, while promoting engraftment, either on a tissue surface or its interior. The cells are contained within wells in the stent that are enclosed by inner and outer membranes that seal the cellular material within the stent until it is to be released. The outer membrane is preferably in the form of a thin, hard plastic sheet having a plurality of score lines, perforations, or other lines or weakening provided therein. The membrane may be embedded in a softer perimetral mount which retains it in position until the seal is to be broken. Rupture of the outer membrane ensures penetration of the cells into the interior of tissue or an organ in which the stent is implanted.

Abstract: An adjustable stenosis provides a channel comprising an outer wall and an inner wall. The inner wall may comprise resiliently flexible material. A reservoir may be formed by the outer wall and inner wall. The flexibility of the inner wall allows the reservoir to expand into the channel to increase stenosis and to contract toward the outer wall to decrease stenosis. The reservoir may have a default expanded shape or a default contracted shape. The default shape may be maintained unless the pressure or amount of filler material in the reservoir is manipulated. The reservoir may have one or more chambers. The channel may be attached to a natural lumen or a graft or may be placed around the lumen or graft.

Abstract: The present invention provides an ex vivo vascular remodeling methods and system by which an excised, small diameter blood vessel can be harvested and expanded to provide viable vascular grafts, as demonstrated at the physical and molecular levels, and as optimized in vivo. The tissue-engineered vessels generated by the present invention closely resemble native vessels in terms of structure, histologically, including endothelial coverage and intricate structural components such as the internal elastic lamina, viability (as measured with MTT assay and TUNEL analysis), and function (vasoactivity, mechanical and biomechanical properties). Thus, the resulting vascular grafts behave in a manner similar to native arteries in terms of mechanical integrity, and provide clinically relevant patency rates when implanted in vivo.

Abstract: A mat having a highly uniform porosity distribution is produced by consolidating 15 or more layers of melt blown webs (or the like) having different orientations. Control over the porosity is provided by using webs that exhibit a narrow, unimodal distribution of fiber diameters over the bulk of its distribution, such as in the top 80%. A compliance of the mats can be chosen by selecting a number and orientation of the webs. It is thus possible to produce mats that are good candidates for vascular grafts, for example. The uniformity of the porosity within the range of 6 ?m to 30 ?m permits seeding of the vascular graft with endothelial and smooth muscle cells. The mats have the demonstrated ability to retain, and support growth of, smooth muscle cells and endothelial cells.

Abstract: Disclosed is an implantable material comprising a biocompatible matrix and cells which, when provided to a vascular access structure, can promote functionality.

Abstract: An endovascular stent comprising an expandable framework including a plurality of interconnected segments, and a plurality of entangled cylindrical micelles disposed on the expandable framework. Each of the plurality of cylindrical micelles may be loaded with a therapeutic agent.

Abstract: Adipose tissue has proven to serve as an abundant, accessible, and rich source of endothelial or vascular endothelial cells suitable for tissue engineering. We describe a detailed method for the isolation and purification of endothelial cells using purified enzymes and antibody-based selection. The cells can be obtained from liposuction procedures and used in vascular grafts.

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.