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EP-4736896-A1 - BIOCOMPATIBLE DEVICE

EP4736896A1EP 4736896 A1EP4736896 A1EP 4736896A1EP-4736896-A1

Abstract

The present invention is a biocompatible device comprising an internal space configured to accommodate cells or tissues that secrete a biologically active substance, wherein the internal space is formed by disposing a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer in the device such that the semi-permeable membrane layer is on the outer side and the non-woven fabric layer is on the internal-space side, the semi-permeable membrane layer comprises a cellulose derivative laminated on a non-woven fabric using the non-woven fabric as a support, and the non-woven fabric layer comprises a thermoplastic non-woven fabric.

Inventors

  • TSUDA Naoto
  • NAKATSUKA SHUJI

Assignees

  • Mochida Pharmaceutical Co., Ltd.

Dates

Publication Date
20260506
Application Date
20240628

Claims (13)

  1. A biocompatible device comprising an internal space configured to accommodate a cell or tissue that secretes a biologically active substance, wherein the internal space is formed by disposing a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer in the device such that the semi-permeable membrane layer is on an outer side and the non-woven fabric layer is on an internal-space side, the semi-permeable membrane layer comprises a cellulose derivative laminated on a non-woven fabric using the non-woven fabric as a support, and the non-woven fabric layer comprises a thermoplastic non-woven fabric.
  2. The device according to claim 1, having immunoisolatability.
  3. The device according to claim 1, wherein the cellulose derivative is cellulose acetate.
  4. The device according to claim 1, wherein the non-woven fabric comprises one or more resins selected from the group consisting of polyethylene, polypropylene, and polyethylene terephthalate.
  5. The device according to claim 1, wherein the internal space is formed by partial fusion of a surface of the non-woven fabric layer that is free of cellulose derivative.
  6. The device according to claim 1, wherein the cell that secretes a biologically active substance is an insulin-secreting cell or a pancreatic islet.
  7. The device according to claim 1, wherein the cell or tissue that secretes a biologically active substance is enclosed in the internal space with a hydrogel serving as a carrier.
  8. The device according to claim 1, wherein the composite membrane has a thickness of 10 to 1500 µm.
  9. The device according to any one of claims 1 to 8, for use in living-donor transplantation.
  10. A biocompatible composite membrane for producing the device according to any one of claims 1 to 8.
  11. A kit for living-donor transplantation, the kit comprising: a biocompatible device having an internal space formed by a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer; and a container including a cell or tissue that secretes a biologically active substance, wherein the kit is used in such a manner that the cell or tissue is enclosed in the internal space.
  12. A method of producing a biocompatible device, the method comprising a step of covering a hydrogel embedding a cell or tissue that secretes a biologically active substance with a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer, wherein, in the step, the semi-permeable membrane layer is disposed on an outer side and the non-woven fabric layer is disposed on a hydrogel side.
  13. A method of producing a biocompatible device, the method comprising a step of injecting a solution comprising a cell or tissue that secretes a biologically active substance and is mixed with a solution capable of hydrogelation into an internal space formed by a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer and gelling the solution capable of hydrogelation, wherein, in the step, the semi-permeable membrane layer is on an outer side and the non-woven fabric layer is on an internal-space side in the composite membrane.

Description

Technical Field The present invention relates to a biocompatible device for transplanting a cell or the like into a living body and a production method therefor, and a kit for living-donor transplantation. Background Art A therapeutic method of transplanting a cell or tissue into a living body is known as one of regenerative therapies for organs with functional disorder, and devices to be used for the therapy have been developed. For example, a technique of a bioartificial pancreas (BAP, also referred to as a bioartificial pancreatic islet), which includes a pancreatic islet covered with (encapsulated in) a polymeric gel, semi-permeable membrane, or the like that enables isolation from immunocytes and the like of a recipient and is permeable to nutritional components, insulin, and others, and is transplanted into a living body, has been examined as a device for treating type 1 diabetes mellitus for some time, and various devices for transplantation have been reported (Patent Literatures 1 to 4). In addition, biocompatible devices for transplantation that are used in therapeutic applications for a disease other than type 1 diabetes mellitus have been reported (Patent Literatures 5 to 7). An immunoisolation device with a membrane produced with polypropylene fiber and ethylene-vinyl alcohol copolymer has been reported (Patent Literature 8). Devices for transplantation with chemically cross-linked alginic acid have been reported (Patent Literatures 9, 10). Citation List Patent Literature Patent Literature 1: Japanese Translation of PCT International Application Publication No. 2022-502458Patent Literature 2: Japanese Patent Laid-Open No. 2019-097442Patent Literature 3: International Publication No. WO 2016/184872Patent Literature 4: Japanese Translation of PCT International Application Publication No. 2017-502008Patent Literature 5: Japanese Translation of PCT International Application Publication No. 2018-515582Patent Literature 6: Japanese Patent Laid-Open No. 2014-200199Patent Literature 7: Japanese Patent Laid-Open No. 2004-209228Patent Literature 8: International Publication No. WO 2022/092198Patent Literature 9: International Publication No. WO 2020/262642Patent Literature 10: International Publication No. WO 2022/137345 Summary of Invention Technical Problem In the circumstances as described above, a novel, practical biocompatible device or the like has been needed. Solution to Problem The present invention has the following features of (1) to (5). (1) The present invention enables production of a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer, wherein the semi-permeable membrane layer comprises a cellulose derivative laminated on a non-woven fabric using the non-woven fabric as a support, and the non-woven fabric layer comprises a thermoplastic non-woven fabric.(2) Use of the composite membrane enables enhancement of membrane strength in covering a hydrogel configured to accommodate a cell, tissue, or the like that secretes a biologically active substance.(3) The configuration in which the non-woven fabric surface of the composite membrane can be fused enables production of a device by heat sealing in a simple manner.(4) In transplanting a device produced with the composite membrane, improved adhesion rates in living bodies and improved cure rates in transplantation subjects are expected.(5) Disposing the non-woven fabric surface of the composite membrane on the inner side allows a hydrogel that is included in an internal space of the device and configured to accommodate a cell, tissue, or the like that secretes a biologically active substance to be fixed on the non-woven fabric surface of the composite membrane, preventing reduction in the survival rate of the cell or the like. More specifically, the present invention relates to: a biocompatible device comprising an internal space configured to accommodate a cell or tissue that secretes a biologically active substance, wherein the internal space is formed by disposing a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer in the device such that the semi-permeable membrane layer is on an outer side and the non-woven fabric layer is on an internal-space side, the semi-permeable membrane layer comprises a cellulose derivative laminated on a non-woven fabric using the non-woven fabric as a support, and the non-woven fabric layer comprises a thermoplastic non-woven fabric; a production method therefor; and others. Exemplary embodiments of the present invention are shown as [1-1] to [4A-3] in the following. [1-1] A biocompatible device having an internal space formed by a biocompatible composite membrane including a semi-permeable membrane layer and a non-woven fabric layer, wherein the semi-permeable membrane layer comprises a cellulose derivative formed on a non-woven fabric serving as a support and the non-woven fabric layer comprises the thermopla