Methods and compositions for consistent intracoronary administration of a biologic

Abstract

Some embodiments provided herein relate to methods, systems and kits for providing consistent intracoronary administration of a biologic to subjects having diverse coronary anatomies. In some embodiments, the biologic is an adeno-associated virus serotype 1 (AAV1) vector encoding sarcoplasmic/endoplasmic reticulum ATPase 2a (SERCA2a) protein.

1 .- 76 . (canceled) 
     
     
         77 . A system for providing consistent intracoronary administration of a biologic to a plurality of subjects having diverse coronary anatomies using multiple types of guide catheters and a single type of biologic-compatible infusion catheter, the system comprising:
 (a) a first guide catheter having proximal and distal ends, wherein the first guide catheter is adapted for the coronary anatomy of a first subject selected from a plurality of subjects comprising diverse coronary anatomies; and   (b) a plurality of kits, each kit comprising:
 (i) a container comprising the biologic, and 
 (ii) an infusion catheter having proximal and distal ends, wherein the infusion catheter is for use in the intracoronary administration of the biologic to a subject, wherein a contact surface of the infusion catheter comprises a material compatible with the biologic, wherein the infusion catheter and biologic in each kit of the plurality of kits are materially identical, and wherein during administration of the biologic to the first subject: 
 the distal end of the first guide catheter is capable of being inserted into a coronary artery or vein of the first subject, and 
 the infusion catheter is capable of being advanced longitudinally within the lumen of the first guide catheter such that the distal end of the infusion catheter is flush with or extends beyond the distal end of the first guide catheter. 
   
     
     
         78 . The system of  claim 77 , wherein the infusion catheter of each kit of the plurality of kits is adapted for insertion into any one of a plurality of different guide catheters; and wherein each guide catheter of the plurality is adapted for a different coronary anatomy of a subject. 
     
     
         79 . The system of  claim 77 , further comprising:
 (c) a second guide catheter having proximal and distal ends, wherein the second guide catheter is adapted for the coronary anatomy of a second subject selected from a plurality of subjects comprising diverse coronary anatomies, wherein the coronary anatomy of the second subject and second guide catheter are each different from the first guide catheter and the coronary anatomy of first subject;   wherein during administration of the biologic to the second subject:
 the distal end of the second guide catheter is capable of being inserted into a coronary artery or vein of the second subject, and 
 the infusion catheter is capable of being advanced longitudinally within the lumen of the second guide catheter such that the distal end of the infusion catheter is flush with or extends beyond the distal end of the second guide catheter. 
   
     
     
         80 . The system of  claim 79 , wherein the coronary anatomy of the first and/or second subject is selected from the group consisting of: non-obstructive or nonocclusive; occluded right coronary artery; occluded left anterior descending artery; occluded left circumflex artery; left dominant circulation; short or non-existent left main coronary artery, with right dominance; and short or non-existent left main coronary artery, with left dominance. 
     
     
         81 . The system of  claim 79 , wherein the first and/or second guide catheter is adapted for delivery of the distal end of the infusion catheter to a left coronary artery, a right coronary artery, a left anterior descending artery, a left circumflex artery, a saphenous vein graft, or a left internal mammary artery graft. 
     
     
         82 . The system of  claim 79 , wherein the first and/or second guide catheter is selected from the group consisting of diagnostic catheter, guide angiographic catheter for selective arterial engagement, guide angiographic catheter for selective venous engagement, and guide angiographic catheter for selective bypass graft engagement. 
     
     
         83 . The system of  claim 77 , wherein each infusion catheter of the plurality of kits has an external diameter in the range from about 0.5 French to about 10 French, and wherein the lumen at the distal end of each of the infusion catheters of the plurality of kits has a diameter in the range from about 0.010 inches to about 0.040 inches. 
     
     
         84 . The system of  claim 77 , further comprising a delivery device selected from the group consisting of a syringe, a stopcock, a manifold, an infusion pump, sterile tubing, and an infusion line, wherein a surface of the delivery device that contacts the biologic during administration is adapted for specific use with the biologic. 
     
     
         85 . The system of  claim 77 , wherein a surface material of a lumen of the guide catheter has not been determined to be compatible with the biologic. 
     
     
         86 . The system of  claim 77 , wherein the guide catheter lacks government-approval for specific use with the biologic. 
     
     
         87 . The system of  claim 77 , wherein a contact surface of the infusion catheter and/or delivery device(s) bind less than 1% of a dose of the biologic. 
     
     
         88 . The system of  claim 77 , wherein a contact surface of the infusion catheter and/or delivery device(s) degrades less than 1% of a dose of the biologic. 
     
     
         89 . The system of  claim 77 , wherein the biologic is selected from the group of an antibody or antigen binding fragment thereof, a vaccine, blood, a blood component, a somatic cell, a tissue, a protein, a recombinant protein, a nucleic acid, a vector for gene therapy, and a viral vector. 
     
     
         90 . The system of  claim 77 , wherein the biologic comprises a vector for gene therapy. 
     
     
         91 . The system of  claim 77 , wherein the biologic comprises an adeno-associated virus (AAV) vector. 
     
     
         92 . The system of  claim 77 , wherein the biologic comprises a therapeutic polynucleotide encoding a sarcoplasmic/endoplasmic reticulum ATPase 2a (SERCA2a) protein. 
     
     
         93 . The system of  claim 77 , wherein the biologic comprises less than or equal to about 2.5×10 14  DNase resistant particles (DRP) adeno-associated virus serotype 1 (AAV1) vector encoding sarcoplasmic/endoplasmic reticulum ATPase 2a (SERCA2a) protein. 
     
     
         94 . The system of  claim 77 , wherein the biologic comprises about 50 ml dose comprising a buffer, sodium chloride, L-histidine, magnesium chloride, polysorbate 20, and water. 
     
     
         95 . The system of  claim 77 , wherein the biologic comprises saline. 
     
     
         96 . The system of  claim 77 , wherein the biologic is lyophilized.