Novel use of antisecretory factor

Abstract

The present invention relates to the use of an antisecretory protein or homologues thereof having the same properties, or certain fragments thereof in the manufacture of a medicament or a medical food for inducing improved rescue of injured or diseased nervous tissue, proliferation, apoptosis, differentiation and/or migration of an embryonic stem cell, adult stem cell, progenitor cell and/or a cell derived from a stem cell or progenitor cell, for treating a condition characterized by or associated with loss and/or gain of cells. In a preferred embodiment, the condition is a neurotrauma or a condition or disease of the CNS and/or PNS and/or ANS, for example, Alzheimer's disease.

1 - 2 . (canceled)  
     
     
         3 . A method of treating and/or preventing a condition associated with or characterised by a pathological loss and/or gain and/or rescue of nervous tissue, comprising administering an antisecretory protein inducing food made from malted cereals in the manufacture of a food or medical food.  
     
     
         4 . A method of treating and/or preventing a condition associated with or characterised by a pathological loss and/or gain and/or rescue of nervous tissue, comprising administering a food or medical food comprising an egg yolk with at least 1000 FIL units/ml, of antisecretory protein.  
     
     
         5 . A method of treating and/or preventing a condition associated with or characterised by a pathological loss and/or gain and/or rescue of nervous tissue, comprising administering a medicament comprising an egg yolk with at least 1000 FIL units/ml, of antisecretory protein.  
     
     
         6 - 15 . (canceled)  
     
     
         16 . A method of inducing the formation of the antisecretory protein according to  claim 23  comprising administering a food and/or drinking solution made from malted cereal.  
     
     
         17 - 19 . (canceled)  
     
     
         20 . A method of propagating, inducing, reducing and/or maintaining the genesis of an isolated stem cell and/or stem cell progeny from any germinal layer in vitro, comprising treating the isolated cell with an antisecretory protein or an oligo- or polypeptide or derivatives thereof comprising an amino acid sequence of Formula I:  
         X1-V-C-X2-X3-K-X4-R-X5   (Formula I; SEQ ID NOS: 3-6)  
       wherein 
 X1 is 1, amino acids nos. 1-35 of SEQ ID NO:2, or is absent  
 X2 is H, R or K  
 X3 is S or L  
 X4 is T or A  
 X5 is amino acids nos. 43-46 (SEQ ID NO: 3), 43-51 (SEQ ID NO: 4), 43-80 (SEQ ID NO: 5) or 43-163 (SEQ ID NO: 6) of SEQ ID NO:1, or is absent; or a pharmaceutically acceptable salt thereof.  
 
     
     
         21 . The method according to  claim 20 , wherein Formula I has a sequence chosen from one of: 
 a) amino acids numbers 35-42 of SEQ ID NO:2,    b) amino acids numbers 35-46 of SEQ ID NO:2,    c) amino acids numbers 36-51 of SEQ ID NO:2,    d) amino acids numbers 36-80 of SEQ ID NO:2,    e) amino acids numbers 1-80 of SEQ ID NO:2, or    f) amino acids numbers 1-163 of SEQ ID NO:2 or a pharmaceutically acceptable salt thereof.    
     
     
         22 . The method according to  claim 20 , wherein said isolated cell is chosen from the group comprising epithelial cells, fibroblasts, osteogenic cells, macrophages and microglial cells, vascular cells, bone cells, chondrocytes, myocardial cells, blood cells, neurons, oligodendrocytes, astroglial cells, progenitor cells, stem cells and/or cells derived from progenitor cells or stem cells.  
     
     
         23 . A method of treatment and/or prevention of a condition associated with or characterised by a pathological loss and/or gain and/or rescue of nervous tissue, comprising administering to a patient in need thereof an effective amount of an antisecretory protein, or an oligo- or polypeptide or derivatives thereof comprising an amino acid sequence of Formula I:  
         X1-V-C-X2-X3-K-X4-R-X5   (Formula I: SEQ ID NOS:3-6)  
       wherein 
 X1 is 1, amino acids nos. 1-35 of SEQ ID NO:2, or is absent  
 X2 is H, R or K  
 X3 is S or L  
 X4 is T or A  
 X5 is amino acids nos. 43-46 (SEQ ID NO: 3), 43-51 (SEQ ID NO: 4), 43-80 (SEQ ID NO: 5) or 43-163 (SEQ ID NO: 6) of SEQ ID NO:1, or is absent; or a pharmaceutically acceptable salt thereof.  
 
     
     
         24 . The A method according to  claim 23 , wherein Formula I has a sequence chosen from one of: 
 a) amino acids nos. 35-42 of SEQ ID NO:2,    b) amino acids nos. 35-46 of SEQ ID NO:2,    c) amino acids nos. 36-51 of SEQ ID NO:2,    d) amino acids nos. 36-80 of SEQ ID NO:2,    e) amino acids nos. 1-80 of SEQ ID NO:2, or    f) amino acids numbers 1-163 of SEQ ID NO:2 or a pharmaceutically acceptable salt thereof.    
     
     
         25 . The method according to  claim 23 , wherein the condition is characterized by displaying a pathological degeneration of, loss of ability and/or loss of control of regeneration of and/or loss of control of regeneration of a differentiated cell and/or tissue, an embryonic stem cell, an adult stem cell, a progenitor cell and/or a cell derived from a stem cell or progenitor cell.  
     
     
         26 . The method according to  claim 23 , wherein the condition is associated with or characterized by a pathological loss and/or gain of cells in the peripheral, autonomic or central nervous system.  
     
     
         27 . The method according to  claim 23 , wherein the condition is associated with or characterized by a pathological loss and/or gain of neural stem cells or neural progenitor cells.  
     
     
         28 . The method according to  claim 23 , wherein the condition is associated with or characterized by a pathological loss and/or gain of oligodendroglial, astroglial, Schwann cells, and/or neuronal cells and/or cell populations.  
     
     
         29 . The method according to  claim 28 , wherein the condition is associated with or characterized by a pathological loss and/or gain of non-cholinergic neuronal cells, cholinergic neuronal cells and/or glial cells, and/or cell populations.  
     
     
         30 . The method according to  claim 23 , wherein the condition is caused by damage to the central nervous system or a defect in the central nervous system.  
     
     
         31 . The method according to  claim 23 , wherein the condition is caused by a traumatic, auto-immune or degenerative disorder.  
     
     
         32 . The method according to  claim 23 , wherein the condition is caused by axonal damage caused by concussion, contusion, axonal damage caused by head trauma, axonal damage caused by small vessel disease in the CNS and/or damage to the spinal cord after disease and/or trauma.  
     
     
         33 . The method according to  claim 23 , wherein said condition is characterised by memory loss.  
     
     
         34 . The method according to  claim 23 , wherein the condition is multiple sclerosis, asphyxia, hypoxic injury, ischemic injury, traumatic injury, Parkinson's disease, Alzheimer's disease, stroke, or demyelinating disorder.  
     
     
         35 . The method according to  claim 23 , wherein the antisecretory protein or the oligo- or polypeptide or derivatives thereof is formulated into a medicament for intravenous infusion, intramuscular injection and/or subcutaneous injection.  
     
     
         36 . The method according to  claim 21 , wherein the antisecretory protein or the oligo- or polypeptide or derivatives thereof is formulated into a medicament so that the active substance will pass into the ventricles and /or other cavities in and/or at a patient's brain when it is administered to said patient.  
     
     
         37 . The method according to  claim 21 , wherein the antisecretory protein or the oligo- or polypeptide or derivatives thereof is formulated into a medicament so that the active substance will pass into the cerebrospinal fluid of a patient when it is administered to said patient.  
     
     
         38 . A method of propagating, inducing, reducing and/or maintaining the genesis of an isolated stem cell and/or stem cell progeny from any germinal layer from a patient, characterized by: 
 a) administering an effective amount of an antisecretory protein or an oligo- or polypeptide or derivatives thereof comprising the amino acid sequence of Formula I as defined in  claim 23  to said patient prior to isolating said cell;    b) propagating said isolated cell in vitro; followed by    c) transplanting said propagated cells into the same or another patient in need thereof.    
     
     
         39 . A method of propagating, inducing, reducing and/or maintaining the genesis of an isolated stem cell and/or stem cell progeny from any germinal layer from a patient, characterized by: 
 a) isolating said cell and/or stem cell progeny from the patient;    b) administering an effective amount of an antisecretory protein or an oligo- or polypeptide or derivatives thereof comprising the amino acid sequence of Formula I as defined in  claim 23  to said isolated cell in vitro and propagating said cells; followed by    c) transplanting said propagated cells back into the same or another patient in need thereof.    
     
     
         40 . The method according to  claim 38 , wherein said isolated cell is selected from the group consisting of fibroblasts, macrophages, vascular cells, bone cells, chondrocytes, myocardial cells, blood cells, neurons, oligodendrocytes, astroglial cells, Schwann cells, progenitor cells, stem cells and/or cells derived from progenitor cells or stem cells.  
     
     
         41 . The method of  claim 23 , wherein the condition is associated with insufficient formation of antisecretory factors.  
     
     
         42 . The method of  claim 23 , wherein the condition is associated with insufficient function of the AF receptors and antisecretory factor binding tissue constituents.