Amniotic fluid formulation for treatment of lung disorders

Abstract

Formulations of human amniotic fluid and methods of use thereof for treatment of lung disorders, and/or injuries 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-1 antitrypsin emphysema, as well as for treatment of acute lung injuries. Methods including administering specifically formulated, diluted sterile de-cellularized 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.

1 . A method of treating or preventing a lung disorder or injury in a human, horse, dog or cat comprising administering to the lung of the human, horse, dog or cat in need of treatment a sterile de-cellularized amniotic fluid, in an amount effective to treat, alleviate, or prevent one or more symptoms of the lung disorder or injury,
 wherein the amniotic fluid is devoid of amniotic cells, micronized membrane, and chorion particles.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1  wherein the amniotic fluid is administered in a dosage unit between about 0.1 cc and about 10.0 cc. 
     
     
         4 . The method of  claim 3  wherein the amniotic fluid is diluted with sterile water, saline or buffer. 
     
     
         5 . The method of  claim 1  wherein the amniotic fluid is administered to the pulmonary or nasal system. 
     
     
         6 . The method of  claim 1  wherein the amniotic fluid is administered in the form of aerosol or with a nebulizer. 
     
     
         7 . The method of  claim 6  wherein the aerosol produces droplets having a size between about 1.5 and 5 microns. 
     
     
         8 . The method of  claim 7  wherein at least 30% of the aerosol droplets have a size between 1.5 and 5 microns in diameter. 
     
     
         9 . The method of  claim 6  wherein the amniotic fluid is administered via a nebulizer. 
     
     
         10 . The method of  claim 1  wherein the amniotic fluid is administered in combination with one or more therapeutic, prophylactic or diagnostic agents. 
     
     
         11 . The method of  claim 10  wherein the amniotic fluid is administered in combination with one or more agents selected from the group consisting of bronchodilators, corticosteroids, methylxanthines, phosphodiesterase-4 inhibitors, anti-angiogenesis agents, antimicrobial agents, antioxidants, anti-inflammatory agents, growth factors, immunosuppressant agents, anti-allergic agents, and combinations thereof. 
     
     
         12 . The method of  claim 1  wherein the lung disorder is selected from the group consisting of chronic obstructive pulmonary disorders (COPD), asthma, emphysema, bronchiectasis, chronic bronchitis, interstitial lung disease, alpha-1 antitrypsin emphysema, and combinations thereof. 
     
     
         13 . The method of  claim 1  wherein the lung injury is an acute inhalation injury caused by exposure to a toxic condition selected from the group consisting of chemical irritants, asphyxiants, burns and smokes, chemical warfare and riot control agents, toxic metals, blast injuries, and combinations thereof. 
     
     
         14 . The method of  claim 1  wherein the amniotic fluid is in an amount effective for improving exercise endurance, increasing baseline blood oxygen saturation, and/or reducing inflammation in the lungs. 
     
     
         15 - 23 . (canceled)