Biomolecular cell encapsulation device and methods of implantation

1. A biomolecular encapsulation device comprising an internal chamber suitable for holding living cells, wherein the internal chamber is disposed between an inner surface of a first semi-permeable layer and an inner surface of a second semi-permeable layer, and the first and second semi-permeable layers are mounted on a supporting frame surrounding a perimeter of the internal chamber; wherein the supporting frame comprises a first frame element that is interconnected to a second frame element, and the first and second frame elements co-operate to position the first and second semi-permeable layers at a predetermined separation distance between the layers

wherein the first frame element comprises (a) a first mounting region to which an outer surface of the first semi-permeable layer is attached and (b) a first spacer region that is unitary with the first mounting region, and

wherein the second frame element comprises (a) a second mounting region to which an outer surface of the second semi-permeable layer is attached and (b) a second spacer region that is unitary with the second mounting region,

such that when the first and second frame elements interconnect the first and second spacer regions are positioned between the first and second mounting regions and together define the predetermined separation distance between the layers.

2. A device according to claim 1 , wherein the first semi-permeable layer is mounted on the first frame element and the second semi-permeable layer is mounted on the second frame element, and the first and second frame elements interconnect to enclose the perimeter of the internal chamber.

3. A device according to claim 1 , wherein the first and second frame elements are ultrasonically welded together.

4. A device according to claim 1 , wherein the first and/or second semi-permeable layer is ultrasonically welded to the frame.

5. A device according to claim 1 , further comprising an adhesive seal between the first and/or second semi-permeable layer and the supporting frame.

6. A device according to claim 1 , wherein the first and second frame elements of the supporting frame cooperate to form a loading port, through which substances can be introduced into the internal chamber.

7. A device according to claim 1 , further comprising an anchoring means for positioning the device within a tissue in vivo.

8. A device according to claim 1 , wherein the first and second semi-permeable layers each comprise a membrane layer in contact with the internal chamber and a mesh layer overlying the membrane layer to the exterior of the internal chamber.

9. A device according claim 8 , wherein the membrane layer comprises polypropylene, polycarbonate, polyethylene terephthalate or polytetrafluoroethylene and/or the mesh layer comprises nylon, titanium, stainless steel, polyethylene terephthalate, polytetrafluoroethylene or polyester.

10. A device according to claim 1 , suitable for holding mammalian cells encapsulated in the internal chamber.

11. A device according to claim 10 , wherein the encapsulated cells are human cells.

12. A device according to claim 10 , wherein the encapsulated cells are cells which are capable of further maturation or differentiation in said device when implanted in vivo in a living mammal.

13. A device according to claim 10 , wherein the encapsulated cells are engineered to express a recombinant product.

14. A device according to claim 10 , wherein the encapsulated cells are capable of producing a therapeutic agent.

15. A device according to claim 10 , wherein the encapsulated cells are used for an immune tolerization or immunizing the recipient.

16. A device according to claim 1 , wherein the first and second frame elements are substantially the same shape.

17. A device according to claim 1 , wherein first and second mounting regions are configured such that the inner surface of the first or second semi-permeable layer is free of the respective mounting surface of the respective mounting region.

18. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 1 , and implanting the device into a living mammal.

19. A method for expressing a recombinant product into a living mammal, comprising encapsulating of cells engineered to express a recombinant product in a device as defined in claim 1 .

20. A method for producing a therapeutic agent into a living mammal, comprising encapsulating of cells engineered to produce a therapeutic agent in a device as defined in claim 1 .

21. A method for inducing an immune tolerization or for immunizing a living mammal, comprising encapsulating immune tolerizing and/or immunizing cells in a device as defined in claim 1 , and implanting the device into a living mammal.

22. A method according to claim 21 , wherein the mammal is non-human.

23. A method according to claim 21 , wherein the encapsulated cells are human cells.

24. A method according to claim 21 , wherein the device is implanted subcutaneously, intrathecally, intraosseous or intracerebrally.

25. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 3 , and implanting the device into a living mammal.

26. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 4 , and implanting the device into a living mammal.

27. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 5 , and implanting the device into a living mammal.

28. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 6 , by introducing the cells into the internal chamber through the loading port, and implanting the device into a living mammal.

29. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 7 , and implanting the device into a living mammal.

30. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 8 , and implanting the device into a living mammal.

31. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 9 , and implanting the device into a living mammal.

32. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 16 , and implanting the device into a living mammal.

33. A method for differentiating cells, comprising encapsulating differentiable cells in a device as defined in claim 17 , and implanting the device into a living mammal.