Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: Disclosed herein are methods of producing pancreatic hormone-expressing cells by first differentiating pluripotent cells in cell culture so as to produce endodermal cells, the endodermal cells being competent to further differentiate into hormone-expressing cells capable of secreting at least one pancreatic hormone in response to a physiological signal, and then, transplanting the cultured endodermal cells into an organism, such as an organism in need of an endocrine cell therapy.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: The present invention relates to methods for encapsulating pancreatic progenitors in a biocompatible semi-permeable encapsulating device. The present invention also relates to production of human insulin in a mammal in response to glucose stimulation.

Abstract: Disclosed are cell encapsulation devices and methods for transplanting cells, such as pancreatic endoderm cells, into a host. In some examples, a cell encapsulation can comprise a lumen configured to receive cells therein, a cell-excluding membrane, where the lumen is internal to the cell-excluding membrane, and a non-woven fabric layer external to the cell-excluding membrane, where the non-woven fabric layer and the cell-excluding membrane comprise perforations. The device can further comprise a woven mesh external to the non-woven fabric layer, where the non-woven fabric layer provides protection to the cell-excluding membrane from direct contact with the woven mesh.

Abstract: The present invention relates to a cryopreserved in vitro cell culture comprising human pancreatic progenitor cells that co-express pancreatic-duodenal homeobox factor-1 (PDX1) and NK6 homeobox 1 (NKX6.1) and are chromogranin negative. The present invention also relates to a method for cryopreserving an in vitro population of human pancreatic progenitor cells that co-express PDX1 and NKX6.1 and are chromogranin negative.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: Disclosed are devices and methods for transplanting cells, such as pancreatic endoderm cells, into a host. The devices include a non-woven fabric external to a cell-excluding membrane, and the non-woven fabric and/or cell-excluding membrane can be perforated. Treatment of the host with immunosuppressive reagents, required to inhibit allograft rejection due to perforations in the cell delivery device, does not compromise maturation or function of transplanted pancreatic endoderm cells.

Abstract: A biocompatible membrane composite including a cell impermeable layer and a mitigation layer is provided. The cell impermeable layer is impervious to vascular ingrowth and prevents cellular contact from the host. Additionally, the mitigation layer includes solid features. In at least one embodiment, mitigation layer has therein bonded solid features. In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded or otherwise connected to each other to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned external to or within the biocompatible membrane composite to provide support to and prevent distortion. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: A biocompatible membrane composite that can provide an environment that is able to mitigate or tailor the foreign body response is provided. The membrane composite contains a mitigation layer and a vascularization layer. A reinforcing component may optionally be included to provide support to and prevent distortion of the biocompatible membrane composite in vivo. The mitigation layer may be bonded (e.g., point bonded or welded) or adhered (intimately or discretely) to an implantable device and/or cell system. The biocompatible membrane composite may be used as a surface layer for implantable devices or cell systems that require vascularization for function but need protection from the host's immune response, such as the formation of foreign body giant cells. The biocompatible membrane composite may partially or fully cover the exterior of an implantable device or cell system. The mitigation layer is positioned between the implantable device or bioactive scaffold and the vascularization layer.

Abstract: Cell encapsulation devices for biological entities and/or cell populations that contain at least one biocompatible membrane composite are provided. The cell encapsulation devices mitigate or tailor the foreign body response from a host such that sufficient blood vessels are able to form at a cell impermeable surface. Additionally, the encapsulation devices have an oxygen diffusion distance that is sufficient for the survival of the encapsulated cells so that the cells are able to secrete a therapeutically useful substance. The biocompatible membrane composite is formed of a cell impermeable layer and a mitigation layer. The cell encapsulation device maintains an optimal oxygen diffusion distance through the design of the cell encapsulation device or through the use of lumen control mechanisms. Lumen control mechanisms include a reinforcing component that is also a nutrient impermeable layer, internal structural pillars, internal tensioning member(s), and/or an internal cell displacing core.

Abstract: A biocompatible membrane composite including a first layer (cell impermeable layer), a second layer (a mitigation layer), and a third layer (a vascularization layer) is provided. The mitigation layer may be positioned between the cell impermeable layer and the vascularization layer In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned on either side of the biocompatible membrane composite or within the biocompatible membrane composite to provide support to and prevent distortion of the membrane composite. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: Disclosed herein are implantable 3-dimensional large capacity device assemblies, specifically, large capacity device assemblies for encapsulating pancreatic progenitor cells for treatment of diabetes.

Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: Disclosed herein are implantable 3-dimensional large capacity device assemblies, specifically, large capacity device assemblies for encapsulating pancreatic progenitor cells for treatment of diabetes.

Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: Disclosed herein are methods of producing pancreatic hormone-expressing cells by first differentiating pluripotent cells in cell culture so as to produce endodermal cells, the endodermal cells being competent to further differentiate into hormone-expressing cells capable of secreting at least one pancreatic hormone in response to a physiological signal, and then, transplanting the cultured endodermal cells into an organism, such as an organism in need of an endocrine cell therapy.