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 improving optic nerve regeneration; preserving or improving the ganglion cell complex, the thickness of the outer retinal layer, or both the ganglion cell complex and the thickness of the outer retinal layer; or preserving or improving the retinal fiber layer in a patient in need thereof comprising: implanting into an eye of the patient a biocompatible capsule comprising
a) a core comprising 0.5-1×10 6 ARPE-19 cells that are genetically engineered to secrete a therapeutically effective amount of CNTF upon implantation, wherein the therapeutically effective amount is between 0.1 and 20 ng/day;
b) a semi-permeable membrane surrounding the core, wherein the membrane has a molecular weight cut off of 50 kD, permits the diffusion of the CNTF therethrough, and 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, and wherein the monofilaments comprise polyethylene terephthalate (PET) fibers that comprise 40-85% of the internal volume of the capsule;
wherein said biocompatible capsule produces 0.6-5.0 ng/day of CNTF for at least 12 months post implantation, and
wherein the capsule is configured as a hollow fiber having an internal diameter of 0.9-1.2 mm and a length of 4-11 mm.
2. The method of claim 1 , wherein the biocompatible capsule produces 0.6-5.0 ng/day of CNTF for at least 2 years post implant.
3. The method of claim 1 , wherein the method preserves or improves visual field sensitivity, contrast, sensitivity, Garway-Heath total deviation, or any combinations thereof.
4. The method of claim 3 , wherein the preservation or improvement of visual field sensitivity or contrast sensitivity corresponds with preservation or improvement of the anatomical structure of the retina.
5. The method of claim 1 , wherein said capsule 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.
6. The method of claim 1 , wherein the biocompatible capsule is anchored to an ocular structure following implantation.
7. The method of claim 1 , wherein the semi-permeable membrane comprises a permselective, immunoprotective membrane.
8. The method of claim 7 , wherein the semi-permeable membrane has a median pore size of 100 nm.
9. The method of claim 1 , wherein one or more ARPE-19 cells in the core are genetically engineered to secrete at least one additional biologically active molecule.