Amniotic fluid formulation for treatment of lung disorders

Abstract

Formulations of human amniotic fluid and methods of use thereof for treatment of chronic lung disorders have been developed. The formulations are suitable for topical delivery to the lung, for treatment of lung disorders including chronic obstructive pulmonary disorders (COPD), asthma, emphysema, bronchiectasis, chronic bronchitis, interstitial lung disease, alpha-I antitrypsin emphysema. Methods including administering specifically formulated, diluted sterile decellularized human amniotic fluids topically to the lungs, preferably as aerosol droplets, are described. In particular the methods involving administration of the amniotic fluid formulation in the form of aerosol droplets with size between about 1.5 μm to about 5 μm, preferably from about 2.5 μm to about 3.5 μm, inclusive, using apparatus such as high-efficiency vibrating mesh nebulizers, are described. Formulations described can treat, or prevent one or more symptoms of a chronic lung disorder

I claim: 
     
         1 . A formulation for treating a lung disorder or injury comprising:
 a sterile, filtered de-cellularized human amniotic fluid (D-HAF) devoice of amniotic stem cells, amniotic membrane particulate;   wherein the formulation is in the form of an aerosol, mist, dry powder, droplet, or a combination thereof.   
     
     
         2 . The formulation of  claim 1 , wherein the formulation is not heat-treated. 
     
     
         3 . The formulation of  claim 1 , wherein the formulation is not chemically-treated. 
     
     
         4 . The formulation of  claim 1 , wherein the formulation is not irradiated. 
     
     
         5 . The formulation of  claim 1 , wherein the formulation is in an amount effective to provide one or more to a lung, alleviate one or more symptoms of the lung disorder, treat the lung disorder, or a combination thereof. 
     
     
         6 . The formulation of  claim 5 , wherein the one or more benefits comprise improving exercise endurance. 
     
     
         7 . The formulation of  claim 1 , wherein the formulation is administered via a pulmonary route, oropharyngeal route, nasopharyngeal route, hypopharyngeal route, or a combination thereof. 
     
     
         8 . The formulation of  claim 1 , wherein the formulation is diluted with sterile water, saline, or a buffer. 
     
     
         9 . The formulation of  claim 1 , wherein at least 50% of the D-HAF has a particle size of between about 1.5 μm and 5 about μm. 
     
     
         10 . The formulation of claim  32 , wherein at least 70% of the D-HAF has a particle size of between about 1.5 μm and 5 about μm. 
     
     
         11 . The formulation of  claim 1 , wherein the D-HAF is administered in combination with one or more therapeutic or diagnostic agents. 
     
     
         12 . The formulation of  claim 1 , wherein the formulation further comprises a bronchodilator, corticosteroid, methylxanthine, phosphodiesterase-4 inhibitor, anti-angiogenesis agent, antimicrobial agent, antioxidant, anti-inflammatory agent, growth factor, immunosuppressant agent, anti-allergic agent, or a combination thereof; or wherein the formulation is administered in combination with a bronchodilator, corticosteroid, methylxanthine, phosphodiesterase-4 inhibitor, anti-angiogenesis agent, antimicrobial agent, antioxidant, anti-inflammatory agent, growth factor, immunosuppressant agent, anti-allergic agent, or a combination thereof. 
     
     
         13 . The formulation of  claim 1 , wherein the formulation is sterilized to a 10 −6  sterility assurance level. 
     
     
         14 . The formulation of  claim 1 , wherein the formulation is administered in a dose unit of between about 0.1 cc and about 10.0 cc. 
     
     
         15 . A kit comprising:
 (1) a container comprising one or more sterile unit doses of the formulation of  claim 1 , and   (2) instructions on how the one or more sterile unit doses are to be used in a nebulizer or an aerosolizer for treatment of the lung disorder or injury.   
     
     
         16 . The kit of  claim 15 , wherein the one or more unit doses are an amount of from about 0.1 cc to about 10.0 cc, and wherein the one or more unit doses are in the form of a solution or a lyophilized powder. 
     
     
         17 . The kit of  claim 15 , wherein the formulation further comprises a pharmaceutically acceptable carrier. 
     
     
         18 . The kit of  claim 15 , wherein the kit further comprises one or more unit doses of sterile water, saline, or a buffer for dilution. 
     
     
         19 . The kit of  claim 15 , wherein the lung disorder is chronic obstructive pulmonary disorders (COPD), asthma, emphysema, bronchiectasis, chronic bronchitis, interstitial lung disease, alpha-1 antitrypsin emphysema, or a combination thereof. 
     
     
         20 . The kit of  claim 15 , wherein the lung injury is an acute inhalation injury caused by exposure to a toxic condition, and wherein the toxic condition comprises a chemical irritant, asphyxiant, burn, smoke, chemical warfare agent, riot control agent, toxic metal, explosion, blast, or a combination thereof.