US2022071897A1PendingUtilityA1

Use of encapsulated cell therapy for treatment of ophthalmic disorders

Assignee: NEUROTECH USA INCPriority: May 27, 2015Filed: Nov 18, 2021Published: Mar 10, 2022
Est. expiryMay 27, 2035(~8.9 yrs left)· nominal 20-yr term from priority
A61K 35/30A61K 9/0051A61K 38/19A61F 9/0017A61K 9/4816A61P 27/06A61K 38/212A61K 38/215A61P 27/02A61K 38/185A61K 38/2066
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         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.

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