Method of culturing viable cells and method of regulating...

C - Chemistry – Metallurgy – 12 – N

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C12N 11/08 (2006.01) A61F 2/02 (2006.01) A61K 9/00 (2006.01) A61K 35/00 (2006.01) A61K 48/00 (2006.01) A61L 27/38 (2006.01) C08G 18/12 (2006.01) C08G 18/48 (2006.01) C08G 18/66 (2006.01) C12N 1/20 (2006.01) C12N 5/00 (2006.01)

Patent

CA 2134088

2134088 9322427 PCTABS00027 A method of culturing live viable cells comprises culturing the cells under the conditions effective for cells to survive in the presence of a non-porous, semi-permeable biocompatible film of predefined characteristics having a tensile strength of 350-10,000 psi, an ultimate elongation of 300-1,500 %, a water absorption such that the sum of the volume fraction of absorbed water in the hydrophilic volume fraction of the soft segment is 100-2,000 % of the dried polymer volume and 50-95 % of the wet polymer volume. The film permeability can be changed to have different cut-off molecular weights while being substantially impermeable to cells and particulate matter as well as high molecular weight molecules. A method of regulating the level of a compound in a body fluid of the subject afflicted with an endogenous defect resulting in abnormal levels of the compound in the body fluid, in the substantial absence of a detrimental immunological reaction comprises: enclosing cells lacking the endogenous defect of the patient's cells in a biocompatible, implantable device, wherein at least one portion thereof comprises a non-porous, semi-permeable, biocompatible film substantially enclosing the cells, the film formed from a copolymer comprising about 5 to 45 wt% of at least one hard segment, and about 95 to 55 wt% of at least one soft segment comprising at least one hydrophilic, hydrophobic or amphipathic oligomer selected from the group consisting of aliphatic polyols, aliphatic and aromatic polyamines and mixtures thereof; the film having a tensile strength greater than about 350 psi and up to about 10,000 psi, an ultimate elongation greater than about 300 % and up to about 1,500 % and a water absorption such that the sum of the volume fraction of absorbed water and the hydrophilic volume fraction of the soft segment exceeds about 100 % and up to about 2,000 % of the dry polymer volume and exceeds about 50 % and up to about 95 % of the wet polymer volume, and the film being permeable to molecules of up to about 6,000 to 600,000 molecular weight and substantially impermeable to cells and particulate matter; implanting the device comprising the cells into a site in the subject's body where the cells are in contact with the subject's body fluid; and allowing the cells to grow at the implantation site where they are in direct interactive contact with the compound and act to regulate its level in the body fluid.

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