Cell or tissue embedding device

#This application is a U.S. National Phase Application of PCT International Application Number PCT/JP2018/006661, filed on Feb. 23, 2018, designating the United States of America and published in the Japanese language, which is an International Application of and claims the benefit of priority to Japanese Patent Application No. 2017-032743, filed on Feb. 23, 2017. The disclosures of the above-referenced applications are hereby expressly incorporated by reference in their entireties.

#The present invention relates to an aqueous gel for forming an immunoisolation layer of a cell or tissue embedding device which enables transplantation of a biological component that produces and/or secretes a physiologically active substance, such as a hormone or a protein, useful for a living organism, or of a biological component that has a detoxifying action on a harmful substance, and after the transplantation, exerts a preventive and/or therapeutic effect on diseases in animals including humans, such as an endocrine disease and a metabolic disease.

#A cell or tissue embedding device is a device which contains living cells, living tissue, or the like and is used as a substitute for an organ etc. of a diseased human or animal for the purpose of preventing and/or treating a disease in a patient by supplying, to the patient, a hormone, a protein, or other physiologically active substances associated with metabolic function, or detoxifying a harmful substance. The cell or tissue embedding device is advantageous in that the living cells or living tissue can be protected by the immunoisolation layer from the biological defense mechanism and therefore the need for immunosuppressant administration and associated side effects can be avoided unlike living organ transplantation, that the operation is less invasive, and that the device enables, in addition to homologous artificial organ transplantation from a dead donor, transplantation of various regenerated stem cells and heterologous artificial organ transplantation, solving the problem of donor shortage.

#FIG. 1 shows the temporal change of the blood sugar levels of diabetic model animals after transplantation of the bioartificial pancreatic islet devices of Example 1 and Example 2.

#FIG. 2 shows the temporal change of the blood sugar levels of diabetic model animals after transplantation of the frozen and thawed pancreatic islet devices of Comparative Examples 1 to 5.

#FIG. 3 shows the temporal change of the blood sugar levels of diabetic model animals after transplantation of the frozen and thawed pancreatic islet devices of Comparative Examples 6 to 11.

#Hereinafter, the present invention will be described in detail.

#The disclosure encompasses a cell or tissue embedding device having an aqueous gel serving as an immunoisolation layer, the aqueous gel that can be prepared in the form of an aqueous solution or a sol containing, as components thereof, a gel-forming polymer material having a main chain resistant to in vivo enzymatic cleavage and an activated carbonyl group, for example, a denatured polyvinyl alcohol resin having an activated carbonyl group (A), and a crosslinking agent (B), the gel-forming polymer material being capable of forming a gel at a temperature of −5° C. or higher. For more significant exertion of the effects of the present invention, the gel-forming polymer material having a main chain resistant to in vivo enzymatic cleavage and an activated carbonyl group, exemplified by a denatured polyvinyl alcohol resin (A), preferably reacts with a crosslinking agent (B) to form a crosslinked 3-dimensional net structure in the aqueous gel or the cell or tissue embedding device.

#A representative embodiment of the aqueous gel of the present invention is an aqueous gel for forming an immunoisolation layer of a cell or tissue embedding device, the aqueous gel containing, as components thereof, a gel-forming polymer material having a main chain resistant to in vivo enzymatic cleavage and a carbonyl group, for example, a denatured polyvinyl alcohol resin having an activated carbonyl group (A), and a crosslinking agent (B). The aqueous gel is prepared by subjecting an aqueous solution or a sol containing the components to temperature reduction to not lower than −5° C.