Repaired organ and method for making the same

Abstract

A repaired ex vivo organ suitable for transplantation in a human, said repaired ex vivo organ having undergone ex vivo organ perfusion for a maintenance period, wherein said organ had been assessed as being unsuitable for transplantation into a human before the maintenance period and was determined to be suitable for transplantation after the maintenance period.

1 . A repaired ex vivo organ suitable for transplantation in a human, said repaired ex vivo organ having undergone ex vivo organ perfusion for a maintenance period, wherein said organ had been assessed as being unsuitable for transplantation into a human before the maintenance period and was determined to be suitable for transplantation after the maintenance period. 
     
     
         2 . The repaired ex vivo organ according to  claim 1 , wherein the repaired organ is a lung and has a best ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of more than 350 mm Hg. 
     
     
         3 . The repaired ex vivo organ according to  claim 1 , wherein the maintenance period is at least 24 hours, 8 hours, or 3 hours. 
     
     
         4 . The repaired ex vivo organ according to  claim 2 , wherein the ex vivo organ was assessed as being unsuitable for transplantation because the organ's best ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen less than 300 mm Hg. 
     
     
         5 . The repaired ex vivo organ according to  claim 1 , wherein the organ has also undergone ex vivo perfusion for a treatment period. 
     
     
         6 . The repaired ex vivo organ according to  claim 5 , wherein the ex vivo organ is a lung and was assessed as being unsuitable for transplantation because it had pulmonary edema, pneumonia, or inflammation. 
     
     
         7 . The repaired organ according to  claim 6 , wherein the ex vivo organ was assessed as having injury or pulmonary edema and was subjected to antibiotics, hyperperfusion techniques, beta-agonists, anti-inflammatory agents, or flow techniques during the treatment period. 
     
     
         8 . The repaired organ according to  claim 6 , wherein the ex vivo organ was assessed as having pneumonia and was subjected to antibiotics or steroids during the treatment period. 
     
     
         9 . The repaired organ according to  claim 6 , wherein the ex vivo organ was assessed as having inflammation and was subjected to gene therapy, stem cells, or anti-coagulants during the treatment period. 
     
     
         10 . The repaired ex vivo organ according to  claim 1 , wherein the organ is a lung, liver, heart, kidney, or pancreas. 
     
     
         11 . A donor organ system for repairing and/or improving a donor organ so that the donor organ is suitable for transplantation into a human, said system comprising the steps of
 (i) determining the status of the organ by evaluating pre-selected criteria;   (ii) subjecting the organ to an acellular perfusate at normothermic temperatures for a maintenance period; and   (iii) determining improvement and/or repair of the organ by re-evaluating the pre-selected criteria.   
     
     
         12 . The donor organ system according to  claim 11 , wherein step (i) is performed concurrently with step (ii). 
     
     
         13 . The donor system according to  claim 11 , further comprising the step of treating the organ with a suitable medical treatment for a treatment period after step (ii). 
     
     
         14 . The donor organ system according to  claim 11 , wherein the organ is a lung, liver, heart, kidney, or pancreas. 
     
     
         15 . The donor organ system according to  claim 11 , wherein the maintenance period is within the range of 1 to 10 hours, 1 to 7 hours, or 1 to 3 hours. 
     
     
         16 . The donor organ system according to  claim 13 , wherein the treatment period is within the range of 1 to 10 hours, 1 to 7 hours, or 1 to 3 hours. 
     
     
         17 . A method of improving an ex vivo organ, said method comprising the steps of:
 (i) determining the status of the organ by evaluating pre-selected criteria;   (ii) subjecting the organ to an acellular perfusate at normothermic temperatures for a maintenance period; and   (iii) determining improvement of the organ by re-evaluating the pre-selected criteria.   
     
     
         18 . The method according to  claim 17 , wherein the organ is a lung, liver, heart, kidney, or pancreas. 
     
     
         19 . The method according to  claim 17 , wherein the ex vivo organ is a lung and the pre-selected criteria include the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 
     
     
         20 . The method according to  claim 19 , where the pre-selected criteria shows an improvement of at least 10%, at least 20%, or at least 40% between steps (i) and (iii).