US2021244771A1PendingUtilityA1

Methods and materials for treating nerve injuries and neurological disorders

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Assignee: PETRUCCI GARY MPriority: Feb 5, 2016Filed: Apr 30, 2021Published: Aug 12, 2021
Est. expiryFeb 5, 2036(~9.6 yrs left)· nominal 20-yr term from priority
A61L 27/3878A61L 2400/06A61L 2430/32A61L 2430/40A61K 35/12A61L 27/507A61K 35/50A61L 27/3683A61L 27/3675A61K 35/28A61L 27/3834A61L 27/3604
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Claims

Abstract

This document provides methods and materials for treating nerve injuries and/or neurological disorders. For example, compositions including an amnion tissue preparation and/or a stem cell preparation as well as methods for using such compositions to treat a nerve injuries and/or neurological disorders are provided.

Claims

exact text as granted — not AI-modified
1 . A nerve scaffold comprising:
 a blood vessel conduit selected from a vein or an artery;   a composition comprising a stem cell preparation having viable cells and an amnion tissue preparation, wherein the amnion tissue preparation is a reconstituted amnion tissue preparation; and   wherein the blood vessel conduit is bathed in the composition.   
     
     
         2 . The nerve scaffold of  claim 1 , wherein the reconstituted amnion tissue preparation is a dried reconstituted amnion tissue preparation. 
     
     
         3 . The nerve scaffold of  claim 2 , wherein the dried reconstituted amnion tissue preparation has a water content of less than about 8 percent. 
     
     
         4 . The nerve scaffold of  claim 2 , wherein the dried reconstituted amnion tissue preparation has a particles size of from about 0.1 um to about 25 um. 
     
     
         5 . The nerve scaffold of  claim 1 , wherein the amnion tissue preparation is a solution comprising amnion tissue and viable cells. 
     
     
         6 . The nerve scaffold of  claim 1 , wherein the amnion tissue preparation a suspension comprising amnion tissue and viable cells. 
     
     
         7 . The nerve scaffold of  claim 1 , wherein the amnion tissue preparation comprises non-viable cells. 
     
     
         8 . The nerve scaffold of  claim 1 , wherein the reconstituted amnion tissue preparation comprises from about 1 mg to about 10 g of amnion tissue per kg of body weight of a recipient mammal. 
     
     
         9 . The nerve scaffold of  claim 1 , wherein the composition further comprises a therapeutic agent, an immunosuppressant agent, or a pharmaceutical excipient. 
     
     
         10 . The nerve scaffold of  claim 1 , wherein the composition comprises from about 5 mg and about 5 g of the reconstituted amnion tissue preparation. 
     
     
         11 . The nerve scaffold of  claim 1 , wherein the reconstituted amnion tissue preparation is void of blood. 
     
     
         12 . The nerve scaffold of  claim 1 , wherein the reconstituted amnion tissue preparation comprises blood and cells. 
     
     
         13 . The nerve scaffold of  claim 1 , wherein the stem cell preparation is a liquid preparation. 
     
     
         14 . The nerve scaffold of  claim 1 , wherein the amnion tissue preparation comprises from about 0.025 million to about 12 million stem cells per kilogram of body weight of a mammal. 
     
     
         15 . An injector device for treating a nerve injury or a neurological disorder in a mammal, the injector device comprising:
 a container comprising a composition comprising a stem cell preparation having viable cells and an amnion tissue preparation wherein the amnion tissue preparation lacks viable cells; and   an injector capable of administering a single dose of the composition.   
     
     
         16 . The injector device of  claim 15 , wherein the amnion tissue preparation is a reconstituted amnion tissue preparation. 
     
     
         17 . The injector device of  claim 15 , wherein the amnion tissue preparation is a dried reconstituted amnion tissue preparation. 
     
     
         18 . The injector device of  claim 15 , wherein the amnion tissue preparation is a solution comprising amnion tissue and viable cells. 
     
     
         19 . The injector device of  claim 15 , wherein the amnion tissue preparation is a suspension comprising amnion tissue and viable cells. 
     
     
         20 . The injector device of  claim 15 , wherein the amnion tissue preparation comprises from about 1 mg to about 10 g of amnion tissue per kg of body weight of a recipient mammal.

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