Submicron particles for the treatment of radiation damage in patients

Abstract

A method of treating a patient exposed to radiation before the patient is thrombocytopenic, comprising: intravenous infusion of protein spheres at a concentration of the protein spheres sufficient to reduce the morbidity and mortality of the irradiated patient. The protein spheres are formed from soluble proteins without the addition of surfactants or detergents, and the protein spheres spontaneously and directly bind at least one coagulation factor without the aid of other molecules which specifically bind the at least one coagulation factor.

What is claimed as being new and desired to be protected by Letters Patent of the United States is as follows: 
     
         1 . A method of treating a patient exposed to radiation before the irradiated patient is thrombocytopenic, said method comprising the steps of:
 treating the irradiated patient before the irradiated patient is thrombocytopenic by intravenous infusion of protein spheres at a concentration of said protein spheres sufficient to reduce the morbidity and mortality of the irradiated patient;   wherein said protein spheres are formed from soluble proteins without the addition of surfactants or detergents, and said protein spheres spontaneously and directly bind at least one coagulation factor without the aid of other molecules which specifically bind the at least one coagulation factor.   
     
     
         2 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising over 99% of said protein spheres are smaller than 1 micron in diameter. 
     
     
         3 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said protein spheres are produced from a source selected from the group consisting of human serum albumin and bovine serum albumin. 
     
     
         4 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said morbidity is selected from the group consisting of radiation-induced anemia, radiation-induced thrombocytopenia, radiation-induced endothelial leakiness, and abnormal response to oxidative stress. 
     
     
         5 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said reduced mortality is a higher percentage of survivors among patients treated with said spheres than patients not treated with said spheres, at a standard time point after the time of radiation. 
     
     
         6 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said reduces mortality is longer days of survival among patients treated with said spheres than patients not treated with said spheres. 
     
     
         7 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising: said protein spheres are albumin spheres. 
     
     
         8 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said administration of protein spheres is administered before the time of irradiation. 
     
     
         9 . The method of treating a patient exposed to radiation in accordance with  claim 1 , further comprising said administration of protein spheres is administered after the time of irradiation and before the onset of thrombocytopenia. 
     
     
         10 . The method of treating a patient exposed to radiation in accordance with  claim 1  where said patient is a cancer patient. 
     
     
         11 . A method of treating a patient exposed to radiation after said patient is thrombocytopenic and said patient has a least one radiation-induced health problem in addition to thrombocytopenia, said method comprising the steps of:
 administering intravenously of submicron protein spheres at a concentration of said protein spheres sufficient to reduce the morbidity and mortality of the irradiated patient;   wherein said protein spheres are formed from soluble proteins without the addition of surfactants or detergents, and said protein spheres spontaneously and directly bind at least one coagulation factor without the aid of other molecules which specifically bind said at least one coagulation factor.   
     
     
         12 . The method of treating a patient exposed to radiation in accordance with  claim 11 , further comprising said morbidity is selected from the group consisting of radiation-induced anemia, radiation-induced thrombocytopenia, radiation-induced endothelial leakiness, and abnormal response to oxidative stress. 
     
     
         13 . The method of treating a patient exposed to radiation in accordance with  claim 11 , further comprising said protein spheres are produced from a source selected from the group consisting of human serum albumin and bovine serum albumin. 
     
     
         14 . The method of treating a patient exposed to radiation in accordance with  claim 11 , further comprising said reduced mortality is a higher percentage of survivors among patients treated with said spheres than patients not treated with said spheres, at a standard time point after the time of irradiation. 
     
     
         15 . The method of treating a patient exposed to radiation in accordance with  claim 11 , further comprising said reduced mortality is longer days of survival among patients treated with said spheres than patients not treated with said spheres. 
     
     
         16 . The method of treating a patient exposed to radiation in accordance with  claim 11 , further comprising said protein spheres are albumin spheres. 
     
     
         17 . A method of treating a patient, said method comprising the steps of:
 intravenous infusion of protein spheres at a dosage of at least 0.1 mg protein sphere per kilogram weight of the patient, where over 99% of said protein spheres have a diameter less than 1 micron;   wherein said protein spheres are formed from soluble proteins without the addition of surfactants or detergents, and said protein spheres spontaneously and directly bind at least one coagulation factor without the aid of other molecules to specifically bind at least one coagulation factor.   
     
     
         18 . The method in accordance with  claim 17 , further comprising said administration of protein spheres is administered before the time the patient is exposed to radiation. 
     
     
         19 . The method in accordance with  claim 17 , further comprising said administration of protein spheres are administered after a time a patient is exposed to radiation and before the onset of thrombocytopenia. 
     
     
         20 . The method in accordance with  claim 17 , further comprising said protein spheres are administered to the patient after the patient is exposed to radiation and after the patient is thrombocytopenic.