US2005038499A1PendingUtilityA1

Methods for coating stents with DNA and expression of recombinant genes from DNA coated stents in vivo

66
Priority: Jun 27, 1997Filed: Sep 22, 2004Published: Feb 17, 2005
Est. expiryJun 27, 2017(expired)· nominal 20-yr term from priority
Inventors:Elizabeth G. NabelGary J. NabelZhi-Yong Yang
A61K 9/0024A61L 2300/416A61K 31/711A61K 48/00A61P 9/00A61K 38/45A61K 38/50A61F 2/82A61L 2300/258A61L 2300/252A61L 31/10A61L 2300/606A61L 31/16
66
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Claims

Abstract

The present invention describes DNA coated stents and methods of using the same to treat or prevent vascular diseases, such as restenosis.

Claims

exact text as granted — not AI-modified
1 - 20 . Cancelled  
     
     
         21 . A method for expressing therapeutically useful amounts of recombinant genes in vivo, comprising the step of placing an implantable device into the vasculature of a patient, wherein the device comprises a biostable intravascular stent coated with a polymer matrix and DNA encoding a therapeutically useful protein, said DNA being uniformly-dispersed within said matrix.  
     
     
         22 . The method of  claim 21 , wherein the therapeutically useful protein is an antiplatelet agent, anticoagulant agent, antimitotic agent, antioxidant, antimetabolite agent, or anti-inflammatory agent.  
     
     
         23 . The method of  claim 21 , wherein the therapeutically useful protein inhibits the proliferation of cells.  
     
     
         24 . The method of  claim 21 , wherein the therapeutically useful protein is thymidine kinase, p16, p21, p27, p57, retinoblastoma or cytosine deaminase.  
     
     
         25 . The method of  claim 24 , wherein the therapeutically useful protein is thymidine kinase or cytosine deaminase.  
     
     
         26 . A method for treating or preventing a vascular disease, comprising the step of placing an implantable device into the vasculature of a patient, wherein the device comprises a biostable intravascular stent coated with a polymer matrix and DNA encoding a protein therapeutically useful for treating the vascular disease, said DNA being uniformly dispersed within said matrix.  
     
     
         27 . The method of  claim 26 , wherein the therapeutically useful protein is an antiplatelet agent, anticoagulant agent, antimitotic agent, antioxidant, antimetabolite agent, or anti-inflammatory agent.  
     
     
         28 . The method of  claim 26 , wherein the therapeutically useful protein inhibits the proliferation of cells.  
     
     
         29 . The method of  claim 26 , wherein the therapeutically useful protein is thymidine kinase, p16, p21, p27, p57, retinoblastoma or cytosine deaminase.  
     
     
         30 . The method of  claim 26 , wherein the therapeutically useful protein is thymidine kinase or cytosine deaminase.  
     
     
         31 . The method of  claim 26 , wherein the vascular disease is restenosis, atherosclerosis, coronary artery bypass graft stenosis or restenosis, arterio-venous fistula stenosis or restenosis, or peripheral artery stenosis or restenosis.  
     
     
         32 . The method of  claim 21 , wherein the DNA is naked DNA.  
     
     
         33 . The method of  claim 21 , wherein the DNA is incorporated into a vector.  
     
     
         34 . The method of  claim 33 , wherein the vector is selected from the group consisting of shuttle vectors, expression vectors, retroviral vectors, adenoviral vectors, adeno-associated vectors and liposomes.  
     
     
         35 . The method of  claim 21 , wherein the therapeutically useful protein is a fusion protein.  
     
     
         36 . The method of  claim 21 , wherein the DNA comprises a sm22α promoter operatively linked to the DNA encoding the therapeutically useful protein.  
     
     
         37 . The method of  claim 26 , wherein the DNA is naked DNA.  
     
     
         38 . The method of  claim 26 , wherein the DNA is incorporated into a vector.  
     
     
         39 . The method of  claim 38 , wherein the vector is selected from the group consisting of shuttle vectors, expression vectors, retroviral vectors, adenoviral vectors, adeno-associated vectors and liposomes.  
     
     
         40 . The method of  claim 26 , wherein the therapeutically useful protein is a fusion protein.  
     
     
         41 . The method of  claim 26 , wherein the DNA comprises a sm22α promoter operatively linked to the DNA encoding the therapeutically useful protein.  
     
     
         42 . The method of  claim 21 , wherein the polymer matrix is formed from an aqueous suspension of DNA and liquid monomeric matrix.  
     
     
         43 . The method of  claim 21 , wherein the stent is a polymeric or metallic stent.  
     
     
         44 . The method of  claim 21 , wherein the stent is stainless steel.  
     
     
         45 . The method of  claim 21 , wherein the stent is coated with about 50 μg to about 5 mg of DNA.  
     
     
         46 . The method of  claim 21 , wherein the polymer matrix comprises fibrin.  
     
     
         47 . The method of  claim 21 , wherein the stent is a polymeric stent comprising poly(ethylene terephthalate), polyacetal, poly(lactic acid), and poly(ethylene oxide)/poly(butylene terephthalate) copolymer.  
     
     
         48 . The method of  claim 26 , wherein the polymer matrix is formed from an aqueous suspension of DNA and liquid monomeric matrix.  
     
     
         49 . The method of  claim 26 , wherein the stent is a polymeric or metallic stent.  
     
     
         50 . The method of  claim 26 , wherein the stent is stainless steel.  
     
     
         51 . The method of  claim 26 , wherein the stent is coated with about 50 μg to about 5 mg of DNA.  
     
     
         52 . The method of  claim 26 , wherein the polymer matrix comprises fibrin.  
     
     
         53 . The method of  claim 26 , wherein the stent is a polymeric stent comprising poly(ethylene terephthalate), polyacetal, poly(lactic acid), and poly(ethylene oxide)/poly(butylene terephthalate) copolymer.  
     
     
         54 . A method for expressing therapeutically useful amounts of recombinant genes in vivo, comprising the step of placing an implantable device into the vasculature of a patient, wherein the device comprises a biostable intravascular stent coated with a polymer matrix and DNA encoding a therapeutically useful protein, said DNA being in contact with said matrix.  
     
     
         55 . The method of  claim 54 , wherein the therapeutically useful protein inhibits the proliferation of cells.  
     
     
         56 . The method of  claim 54 , wherein the therapeutically useful protein is thymidine kinase, p16, p21, p27, p57, retinoblastoma, protein or cytosine deaminase.

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