Biologic Scaffold For Prevention of Pulmonary Fibrosis

Abstract

Provided herein are methods of preventing, lessening or treating pulmonary fibrosis in a subject. The methods comprise delivering an amount of a powdered extracellular matrix (ECM)-derived material to the respiratory system of the subject effective to prevent, lessen or treat pulmonary fibrosis in a subject. Also provided is an apparatus for delivering the powdered ECM-derived material to a subject.

We claim: 
     
         1 . An apparatus for reducing or preventing development of interstitial lung disease in a subject, comprising:
 an airway delivery system to administer via the subject's airway a composition comprising a devitalized, decellularized extracellular matrix material comprising epithelial basement membrane that is delaminated from one or more layers of a devitalized epithelial tissue in an amount that is effective to reduce or prevent development interstitial lung disease in the subject, said airway delivery system selected from the group consisting of a meter-dosed inhaler, nebulizer, spray, and aerosolizer.   
     
     
         2 . The apparatus of  claim 1 , wherein the airway delivery system is a metered dose inhaler. 
     
     
         3 . The apparatus of  claim 1 , wherein the airway delivery system is a metered-dose device and the composition further comprises a propellant. 
     
     
         4 . The apparatus of  claim 1 , wherein the composition comprises a dry powder. 
     
     
         5 . The apparatus of  claim 1 , wherein the apparatus is an intra-tracheal delivery device. 
     
     
         6 . The apparatus of  claim 1 , wherein the airway delivery system comprises an endotracheal tube or an adapter for an endotracheal tube. 
     
     
         7 . The apparatus of  claim 1 , wherein the composition comprises a liquid. 
     
     
         8 . The apparatus of  claim 4 , wherein the powdered composition has a maximum particle size of 250 μM. 
     
     
         9 . The apparatus of  claim 4 , wherein the powdered composition has a maximum particle size of 75 μM. 
     
     
         10 . The apparatus of  claim 1 , wherein the extracellular matrix material is derived from urinary bladder. 
     
     
         11 . The apparatus of  claim 1 , wherein the interstitial lung disease is associated with silicosis;
 asbestosis; berylliosis; hypersensitivity pneumonitis; drug induced interstitial lung disease, connective tissue disease, systemic sclerosis, dermatomyositis, systemic lupus erythematosus, rheumatoid arthritis; infection, atypical pneumonia, pneumocystis pneumonia (PCP), tuberculosis; idiopathic interstitial lung disease, sarcoidosis, idiopathic pulmonary fibrosis, Hamman-Rich syndrome, a malignancy, or lymphangitic carcinomatosis.   
     
     
         12 . The apparatus of  claim 1 , wherein said airway delivery system is capable of delivering of about 10 μg to about 1000 mg of the composition to the subject. 
     
     
         13 . The apparatus of  claim 1 , wherein said airway delivery system is capable of delivery an amount of said composition in a solution to the subject in the range of 1 μg/ml to 100 mg/ml, 100 μg/ml to 10 μg/ml, or 5 μg/ml to 1 mg/ml, or 4 mg/ml. 
     
     
         14 . The apparatus of  claim 1 , wherein said extracellular matrix material further comprises tunica propria. 
     
     
         15 . The apparatus of  claim 14 , wherein the extracellular matrix material further comprises submucosa. 
     
     
         16 . The apparatus of  claim 1 , wherein the composition is solubilized. 
     
     
         17 . The apparatus of  claim 1 , wherein said extracellular matrix material is derived from a tissue selected from the group consisting of trachea, lung, small intestine, and skin. 
     
     
         18 . A compound for reducing or preventing interstitial lung disease in a patient, comprising:
 an ECM-derived material comprising epithelial basement membrane; and   an excipient selected from the group consisting of antiadherents, binders, rheology modifiers, coatings, disintegrants, emulsifiers, oils, buffers, salts, acids, bases, fillers, diluents, solvents, flavors, colorants, glidants, lubricants, preservatives, antioxidants, sorbents, vitamins, sweeteners and compositions that enhance solubility of the compound.