USE OF ENCAPSULATED CELL THERAPY FOR TREATMENT OF OPHTHALMIC DISORDERS
Described herein are methods and devices for the long term treatment of ophthalmic disorders. Also disclosed are encapsulated cell therapy (ECT) devices that secrete a biologically active molecule and methods for using the same for the treatment of various kinds of ophthalmic disorders, including retinitis pigmentosa, geographic atrophy (dry age-related macular degeneration), glaucoma and/or macular telangiectasia.
1 . A method of treating Geographic Atrophy in a patient suffering therefrom comprising: implanting into an eye of the patient a biocompatible device comprising
a) a core comprising between 5×10 2 and 6×10 5 ARPE-19 cells that are genetically engineered to secrete a therapeutically effective amount of ciliary neurotrophic factor (CNTF), wherein the therapeutically effective amount of CNTF is between 0.1 ng/eye/day and 50 ng/eye/day,
b) a semi-permeable membrane surrounding the core, wherein the membrane has a molecular weight cut off of 50 kD and permits the diffusion of the biologically active molecule therethrough and wherein the semi-permeable membrane is between 90 and 120 μm thick, and
c) a matrix disposed within the semi-permeable membrane, wherein said matrix comprises monofilaments that are twisted into a yarn that is in non-woven strands, wherein the cells are distributed thereon, wherein the monofilaments comprise polyethylene terephthalate; and
wherein said biocompatible device produces therapeutically effective amounts of the biologically active molecule for at least 12 months post implantation.
2 . The method of claim 2 , wherein the biocompatible device produces therapeutically effective amounts of the biologically active molecules for at least 2 years post implant.
3 . The method of claim 1 , wherein the biocompatible device is configured as a hollow fiber.
4 . The method of claim 3 , wherein the biocompatible device has an internal diameter of between 0.9 mm-1.2 mm.
5 . The method of claim 1 , wherein the biocompatible device is configured as a flat sheet.
6 . The method of claim 1 , wherein the monofilaments comprise between 40-85% of the internal volume of the device.
7 . The method of claim 1 , wherein said device is implanted in the vitreous, in the aqueous humor, in the periocular space, in the anterior chamber, in the posterior chamber, or in the Subtenon's space.
8 . The method of claim 7 , wherein the biocompatible device is anchored to an ocular structure following implantation.
9 . The method of claim 1 , wherein the semi-permeable membrane comprises a permselective, immunoprotective membrane.
10 . The method of claim 9 , wherein the semi-permeable membrane has a median pore size of 100 nm.
11 . The method of claim 1 , wherein the length of the biocompatible device is between 4 mm-11 mm.
12 . The method of claim 1 , wherein at least one additional biologically active molecule is co-delivered from the biocompatible device.
13 . The method of claim 12 , wherein the at least one additional biologically active molecule is from a non-cellular source.
14 . The method of claim 12 , wherein the at least one additional biologically active molecule is from a cellular source.
15 . The method of claim 14 , wherein the at least one additional biologically active molecule is produced by one or more genetically engineered ARPE-19 cells in the core.
16 . The method of claim 1 , wherein the method improves visual acuity, macular volume or retinal thickness in a patient suffering therefrom.