Encapsulation of pancreatic cells derived from human pluripotent stem cells

• US 10,272,179 B2
• Filed: 08/16/2017
• Issued: 04/30/2019
• Est. Priority Date: 11/14/2008
• Status: Active Grant

• Current Assignee: Viacyte Incorporated (Vertex Pharmaceuticals Incorporated)
• Original Assignee: Viacyte Incorporated (Vertex Pharmaceuticals Incorporated)
• Inventors: Martinson, Laura, Green, Chad, Kroon, Evert, Baetge, Emmanuel Edward
• Primary Examiner(s): Chen, Shin Lin
• Application Number:
  US15/679,002
• Publication Number:
  US 20170354760A1
• Time in Patent Office: 622 Days
• Field of Search: 604500, 604 9301, 424423, 424424, 435366
• CPC Class Codes: A01N 1/0221 Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61K 2035/126 Immunoprotecting barriers, e.g. jackets, diffusion chambers
• CPC Class Codes: A61K 35/39 Pancreas; Islets of Langerhans Langerhans cells of epidermis A61K35/36
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/62 Encapsulated active agents, e.g. emulsified droplets
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin
• CPC Class Codes: C12N 2501/115 : Basic fibroblast growth factor (bFGF, FGF-2)
• CPC Class Codes: C12N 2501/117 : Keratinocyte growth factors (KGF-1, i.e. FGF-7; KGF-2, i.e. FGF-12)
• CPC Class Codes: C12N 2501/119 : Other fibroblast growth factors, e.g. FGF-4, FGF-8, FGF-10
• CPC Class Codes: C12N 2501/16 : Activin; Inhibin; Mullerian inhibiting substance
• CPC Class Codes: C12N 2501/19 : Growth and differentiation factors [GDF]
• CPC Class Codes: C12N 2501/385 : of the family of the retinoic acid recptor, e.g. RAR, RXR; Peroxisome proliferator-activated receptor [PPAR]
• CPC Class Codes: C12N 2501/41 : Hedgehog proteins; Cyclopamine (inhibitor)
• CPC Class Codes: C12N 2501/415 : Wnt; Frizzeled
• CPC Class Codes: C12N 2506/02 : from embryonic cells
• CPC Class Codes: C12N 5/0676 : Pancreatic cells
• CPC Class Codes: C12N 5/0678 : Stem cells; Progenitor cells; Precursor cells

Abstract

The present invention relates to a perforated semi-permeable device comprising, human pancreatic endocrine cells or human PDX1-positive pancreatic endoderm cells contained within a semi-permeable membrane comprising a synthetic material, wherein the synthetic material is polysulfone (PSF), nano-fiber mats, polyimide, tetrafluoroethylene/polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyacrylonitrile, polyethersulfone, acrylic resin, cellulose acetate, cellulose nitrate, polyamide, or hydroxylpropyl methyl cellulose (HPMC), a cell encapsulation chamber, and at least one seal that is within the cell encapsulation chamber.

Claims

1. A perforated semi-permeable device comprising

human pancreatic endocrine cells within a semi-permeable membrane comprising a synthetic material, wherein the synthetic material is polysulfone (PSF), nano-fiber mats, polyimide, tetrafluoroethylene/polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyacrylonitrile, polyethersulfone, acrylic resin, cellulose acetate, cellulose nitrate, polyamide, or hydroxylpropyl methyl cellulose (HPMC);

a cell encapsulation chamber bounded by the semi-permeable membrane; and

at least one seal that is within the cell encapsulation chamber, wherein the at least one seal within the cell encapsulation chamber does not increase the surface area of the cell encapsulation chamber relative to the absence of the at least one seal.

2. The device of claim 1, wherein the device comprises more than one cell encapsulation chamber.

3. The device of claim 1, wherein the device is refillable.

4. The device of claim 1, wherein the device is vascularized on the exterior and interior of the device.

5. The device of claim 1, wherein the synthetic material is PTFE.

6. The device of claim 1, wherein the synthetic material is ePTFE.

7. A perforated semi-permeable device comprising

a human pancreatic and duodenal homeobox factor 1 (PDX1) positive pancreatic endoderm cell population within a semi-permeable membrane consisting of a synthetic material, wherein the synthetic material is polysulfone (PSF), nano-fiber mats, polyimide, tetrafluoroethylene/polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyacrylonitrile, polyethersulfone, acrylic resin, cellulose acetate, cellulose nitrate, polyamide, or hydroxylpropyl methyl cellulose (HPMC);

a cell encapsulation chamber bounded by the semi-permeable membrane; and

at least one seal that is within the cell encapsulation chamber, wherein the at least one seal within the cell encapsulation chamber does not increase the surface area of the cell encapsulation chamber relative to the absence of the at least one seal.

8. The device of claim 7, wherein the device comprises more than one cell encapsulation chamber.

9. The device of claim 7, wherein the device is refillable.

10. The device of claim 7, wherein the device is vascularized on the exterior and interior of the device.

11. The device of claim 7, wherein the synthetic material is PTFE.

12. The device of claim 7, wherein the synthetic material is ePTFE.

13. A perforated semi-permeable device comprising

a human pancreatic endocrine cell population within a semi-permeable membrane consisting of expanded polytetrafluoroethylene (ePTFE);

a cell encapsulation chamber bounded by the semi-permeable membrane; and

at least one seal that is within the cell encapsulation chamber, wherein the at least one seal within the cell encapsulation chamber does not increase the surface area of the cell encapsulation chamber relative to the absence of the at least one seal.

14. The device of claim 13, wherein the device comprises more than one cell encapsulation chamber.

15. The device of claim 13, wherein the device is refillable.

16. The device of claim 13, wherein the device is vascularized on the exterior and interior of the device.