Dosing regimens for neural stem cell proliferating agents and differentiating agents for the treatment of neurological disorders

Abstract

Effective dosing regimens for neural stem cell proliferating and differentiating agents, kits comprising effective dosing regimens for neural stem cell proliferating and differentiating agents, and uses thereof are provided herein. Such kits and methods can be utilized acutely or chronically to treat a neurodegenerative disease or condition. Furthermore, the compositions and methods can be used continuously or intermittently in various dosing regimens.

1 - 29 . (canceled) 
     
     
         30 . A method of treating or ameliorating a neurodegenerative disease or condition in a mammal comprising administering to the mammal an effective amount of hCG, LH, or a combination thereof, in a first treatment period followed by an effective amount of EPO in a second treatment period,
 wherein the hCG comprises native hCG alpha and beta subunits, or variants thereof having at least 80% sequence identity to native hCG and alpha and beta subunits, and is a functional agonist of native hCG receptor,   wherein the LH comprises native human LH, or a variant thereof having at least 80% sequence identity to native human LH, and is a functional agonist of native human LH receptor,   wherein the EPO comprises native human EPO, or a variant thereof having at least 80% sequence identity to native human EPO, and is a functional agonist of native EPO receptor, and   wherein the second treatment period begins at least one day after the first treatment period.   
     
     
         31 . The method of  claim 30 , wherein a first dose of hCG or LH is administered to the mammal within 0 to about 14 days of an onset of symptoms or a diagnosis of the neurodegenerative disease or condition. 
     
     
         32 . The method of  claim 30 , wherein the first dose of hCG or LH is administered to the mammal within 0 to about 5 days of an onset of symptoms or a diagnosis of the neurodegenerative disease or condition. 
     
     
         33 . The method of  claim 30 , wherein the first treatment period is at least about three, four, five, six, seven, or fourteen days. 
     
     
         34 . The method of  claim 30 , wherein the second treatment period is at least about three, four, five, six, seven, or fourteen days. 
     
     
         35 . (canceled) 
     
     
         36 . The method of  claim 30 , wherein the hCG or LH is delivered intermittently during the first treatment period and the EPO is delivered continuously during the second treatment period. 
     
     
         37 . The method of  claim 36 , wherein the hCG or LH is delivered on days 1, 3, and 5 of the first treatment period and the EPO is delivered on days 1, 2, and 3 of the second treatment period. 
     
     
         38 - 52 . (canceled) 
     
     
         53 . The method of  claim 30 , wherein the neurodegenerative disease or condition is a CNS injury. 
     
     
         54 . The method of  claim 53 , wherein the CNS injury is a traumatic brain or spinal cord injury. 
     
     
         55 . The method of  claim 30 , wherein a dosage unit of hCG provides a blood serum level of hCG of about 0.03 IU/L to about 5,000,000 IU/L in the mammal. 
     
     
         56 . The method of  claim 30 , wherein a dosage unit of hCG provides a cerebral spinal fluid level of hCG of about 0.003 IU/L to about 5,000 IU/L in the mammal. 
     
     
         57 . The method of  claim 30 , wherein the amount of hCG administered to the mammal is about 0.5 IU/kg/day to about 3,000,000 IU/kg/day. 
     
     
         58 . The method of  claim 30 , wherein the amount of hCG administered to the mammal is about 10,000 IU/day. 
     
     
         59 . The method of  claim 30 , wherein the amount of LH administered to the mammal is about 0.5 IU/kg/day to about 300,000 μg/kg/day. 
     
     
         60 . The method of  claim 30 , wherein the amount of an LH administered to the mammal is about 10,000 IU/day. 
     
     
         61 . The method of  claim 30 , wherein the amount of EPO administered to the mammal is about 100-1000 IU/kg/day. 
     
     
         62 . The method of  claim 30 , wherein the amount of EPO administered to the mammal is about 570-950 IU/kg/day. 
     
     
         63 . The method of  claim 30 , wherein the amount of EPO administered to the mammal is about 765 IU/kg/day. 
     
     
         64 . The method of  claim 30 , wherein the amount of EPO administered to the mammal is about 30,000 IU/day. 
     
     
         65 . The method of  claim 30 , wherein 10,000 IU/day of hCG and 30,000 IU/day of EPO are administered to the mammal.