Amniotic fluid formulation for treatment of joint pain or disorders

Abstract

A human amniotic fluid formulation has been developed for administration into a joint or associated soft tissue such as a tendon or ligament for treatment of pain, degeneration, or injury. The formulation is a sterile de-cellularized human amniotic fluid (D-HAF), devoid of amniotic stem cells and elements of micronized membrane or chorion particles, which has not been heat treated or treated with ethidium bromide. The formulation is optionally diluted, or concentrated, depending on the severity of the disorder or injury. Examples demonstrate efficacy in treatment of pain, disease, disorder, degeneration or injury of a joint or associated soft tissues.

What is claimed: 
     
         1 . A method of promoting repair and/or regeneration of cartilage in a subject comprising administering to or adjacent to a site in need thereof an effective amount of a sterile, de-cellularized, human amniotic fluid (D-HAF). 
     
     
         2 . The method of  claim 1  wherein D-HAF is devoid of amniotic stem cells, elements of micronized membrane, and chorion particles. 
     
     
         3 . The method of  claim 1  wherein D-HAF comprises at least 300 human growth factors. 
     
     
         4 . The method of  claim 1 , wherein the site in need thereof is a joint. 
     
     
         5 . The method of  claim 1 , wherein the cartilage is tibial cartilage. 
     
     
         6 . The method of  claim 1 , wherein D-HAF is administered in an amount effective to regenerate articular cartilage in the femoral, tibial, and/or patellar articular surfaces. 
     
     
         7 . The method of  claim 4 , wherein the joint has pain, arthritis, osteochondrosis, fibrous dysplasia, and/or a bone tumor. 
     
     
         8 . The method  claim 7 , wherein the joint has degeneration, cartilage wear or tear, and/or joints that have been fractured. 
     
     
         9 . The method of  claim 7 , including administering D-HAF to bones with prosthetic implants, pins, or screws, the D-HAF administered to promote healing, repair, and/or to reduce inflammation. 
     
     
         10 . A method for preventing bone loss or promoting bone formation in a subject in need thereof comprising administering to or adjacent to a site in need thereof an effective amount of a sterile de-cellularized human amniotic fluid (D-HAF) devoid of amniotic stem cells, to reduce one or more symptoms of bone loss, prevent one or more symptoms of bone loss, promote bone formation, or combinations thereof, in the subject relative to an untreated control. 
     
     
         11 . The method of  claim 10 , wherein the subject has osteopenia or osteoporosis. 
     
     
         12 . The method of  claim 10 , wherein the subject has a bone fracture or needs a spinal fusion. 
     
     
         13 . The method of  claim 10 , wherein the subject is an animal. 
     
     
         14 . The method of  claim 13 , wherein the animal comprises a dog, cat, horse, or livestock. 
     
     
         15 . The method of  claim 14 , wherein the animal has arthritis, bursitis, tendinitis, and/or tenosynovitis. 
     
     
         16 . A composition comprising D-HAF and one or more pharmaceutically acceptable excipients and/or additives. 
     
     
         17 . The composition of  claim 16 , wherein D-HAF comprises a D-HAF formulation, the D-HAF formulation comprising a lyophilized formulation or fluid formulation. 
     
     
         18 . The composition of  claim 17 , wherein the lyophilized formulation comprises a lyophilisate. 
     
     
         19 . The composition of  claim 18 , wherein the lyophilisate is stored in a refrigerated condition at +2° C. to about +25° C. 
     
     
         20 . The composition of  claim 16 , wherein the process by which D-HAF is prepared comprises: (a) collecting human amniotic fluid from a caesarean section to produce a sample of raw amniotic fluid; (b) centrifuging the sample of raw amniotic fluid at 5,000 to 10,000 rpm for 30 minutes to 1 hour; and (c) collecting the supernatant. 
     
     
         21 . The process of  claim 20 , wherein the final filtrate is stored in frozen condition at about −20° C. to about −80° C.