US2012045460A1PendingUtilityA1

Methods and compositions for treatment of graft rejection and promotion of graft survival

56
Individually held — no corporate assignee on recordPriority: Jun 7, 2005Filed: Apr 22, 2011Published: Feb 23, 2012
Est. expiryJun 7, 2025(expired)· nominal 20-yr term from priority
Inventors:Eli C. LewisCharles A. DinarelloLeland Shapiro
A61P 37/06A61P 3/10A61P 37/02A61P 29/00A61K 38/191A61K 38/217A61K 35/39A61K 38/57A61K 45/06A61K 2039/505A61P 17/02C07K 16/40A61P 1/18
56
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Claims

Abstract

Embodiments of the present invention illustrate methods of treating and preventing transplantation and side effects associated with transplantation. In certain embodiments, compositions and methods relate to inhibition of graft rejection and promotion of graft survival. Thus, the invention relates to modulation of cellular activities, including graft rejection, promotion of graft survival, graft versus host rejection, islet cell preservation and conditions commonly associated with graft rejection. Other embodiments relate to the inhibitory compounds comprising naturally occurring and man-made inhibitors of serine protease and inducers of other alpha1-antitrypsin activities.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A method for reducing the risk of a transplant rejection in a subject, said method comprising administering to the subject at least one commercially available composition comprising alpha1-antitrypsin. 
     
     
         2 . The method of  claim 1 , wherein the composition comprises one or more of Prolastin®-C (Talecris), Aralast® (Baxter), Kamada compositions or combinations thereof. 
     
     
         3 . The method of  claim 1 , wherein the composition further comprises one or more anti-transplant rejection agent, anti-inflammatory agent, immunosuppressive agent, immunomodulatory agent, anti-microbial agent, or a combination thereof. 
     
     
         4 . The method of  claim 1 , wherein the composition is Prolastin®-C. 
     
     
         5 . The method of  claim 1 , wherein the transplant is selected from an organ or non-organ transplant. 
     
     
         6 . The method of  claim 5 , wherein the organ transplant is selected from the group consisting of lung, kidney, heart, liver, soft tissue, skin, pancreas, intestine and a combination thereof. 
     
     
         7 . The method of  claim 5 , wherein the non-organ transplant is selected from the group consisting of cornea, bone marrow, stem cell, pancreatic islet, and a combination thereof. 
     
     
         8 . A method for treating a subject in need of immunotolerance therapy, said method comprising administering to the subject a therapeutically effective amount of a commercially available composition comprising a alpha-1-antitrypsin. 
     
     
         9 . The method of  claim 8 , wherein the composition comprises one or more of Prolastin®-C (Talecris), Aralast® (Baxter), Kamada compositions or combinations thereof 
     
     
         10 . The method of  claim 8 , wherein the composition significantly reduces the need for immunosuppressive therapy. 
     
     
         11 . The method of  claim 8 , wherein the composition further comprises one or more anti-inflammatory agent, immunosuppressive agent, immunomodulatory agent, anti-microbial agent, or a combination thereof. 
     
     
         12 . The method of  claim 8 , wherein the immunotolerance therapy is selected from the group consisting of reducers of apoptosis production, reducers of cytokine production, reducers of nitric oxide production and a combination thereof. 
     
     
         13 . The method of  claim 12 , wherein inhibition of cytokine production is selected from the group consisting of inhibition of TNFα (tumor necrosis factor alpha), IL-1 (interleukin-1), IL-12 (interleukin-12), IL-18 (interleukin-18), IFNγ (interferon gamma) and a combination thereof. 
     
     
         14 . A method for reducing the risk of a non-organ transplant rejection in a subject, said method comprising administering to the subject a commercially available composition comprising alpha1-antitrypsin. 
     
     
         15 . The method of  claim 14 , wherein non-organ transplant rejection comprises graft versus host disease (GVHD). 
     
     
         16 . The method of  claim 14 , wherein the composition comprises one or more of Prolastin®-C (Talecris), Aralast® (Baxter), Kamada compositions or combinations thereof 
     
     
         17 . The method of  claim 14 , further comprising one or more anti-rejection agent, anti-inflammatory agent, immunosuppressive agent, immunomodulatory agent, anti-microbial agent, anti-viral or combination thereof. 
     
     
         18 . A method for preserving an explanted organ or non-organ, said method comprising administering to the organ or non-organ, a commercially available AAT composition. 
     
     
         19 . The method of  claim 18 , wherein preserving the explant comprises preserving the explant any time prior to implanting the organ or non-organ into a recipient. 
     
     
         20 . The method of  claim 19 , wherein preserving an explant is selected from the group consisting of reducing apoptosis in the explant, reducing cytokine production in the explant, reducing nitric oxide production in the explant and a combination thereof. 
     
     
         21 . A method for preserving or modulating islet cell functions comprising, commercially available alpha1-antitrypsin provided to an islet cell and preserving or modulating islet cell functions. 
     
     
         22 . The method of  claim 21 , wherein the composition is administered to a subject having Type 1 diabetes, wherein the composition preserves the subject's islet cell functions. 
     
     
         23 . The method of  claim 21 , wherein the composition is administered to a subject having Type 2 diabetes, wherein the composition preserves the subject islet cell functions. 
     
     
         24 . The method of  claim 21 , wherein the composition is administered to a subject undergoing an islet cell transplant or islet cell infusion. 
     
     
         25 . The method of  claim 21 , wherein the composition is administered to a subject having loss of islet cell function related to systemic or pancreatic inflammation. 
     
     
         26 . The method of  claim 21 , wherein the composition is administered to a subject having suffered from a burn that induces islet cell destruction. 
     
     
         27 . The method of  claim 21 , wherein preserving or modulating islet cell functions comprise preserving or modulating production of insulin; islet cell viability; inhibition of production, release, levels, half-life, activity or combination thereof of chemokines; inhibition of nitric oxide levels; and inhibition of inflammatory cytokine production, release, levels, half-life, activity or combination thereof. 
     
     
         28 . The method of  claim 21 , wherein the composition comprises one or more of Prolastin®-C (Talecris), Aralast® (Baxter), Kamada compositions or combinations thereof. 
     
     
         29 . The method of  claim 21  wherein the composition is Prolastin®-C. 
     
     
         30 . The method of  claim 21 , wherein a subject is administered the composition and the subject is a mammalian subject. 
     
     
         31 . The method of  claim 21 , wherein the mammalian subject is an adult or a juvenile. 
     
     
         32 . The method of  claim 21 , wherein the composition reduces the level of macrophage inflammatory protein 1 expressed by the islet cells.

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