Lyophilized platelet rich plasma for the use in wound healing (chronic or acute) and bone or tissue grafts or repair

Abstract

This invention relates to an improved Lyophilized platelet rich plasma used to make a platelet gel wound healant, and methods of preparation and use thereof for healing wounds are disclosed. The improved wound healant comprises therapeutically effective amounts of activated growth factors, platelet ghost, plasma (know as the plasma back bone), white blood cells with optional none, one or more additional anti-oxidant such as vitamin A and/or C and/or E, and/or none one or more antibiotics and/or GHK-Cu (produced by ProCyte Inc.)

1 . A dehydrated composition, useful for mammalian therapy, comprising: substantially shelf-stable freeze-dried platelets selected from the mammalian species for which therapy is intended, the platelets being effectively loaded with fresh or fresh frozen plasma Less than  6  hours old for biological properties during freeze-drying and rehydration, wherein the platelets are rehydratable so as to have a normal response to at least one agonist.  
     
     
         2 . The method of  claim 1  wherein said composition is lyophilized.  
     
     
         3 . The method of  claim 2  where in said composition is frozen to −50° C. for 4 hours and −20° C. for the duration of the procedure and not allowing to warm up above −20° C. during the entire process of Lyophilization.  
     
     
         4 . The method of  claim 2  where said composition is lyophilized for 24 to 60 hours.  
     
     
         5 . A wound healant described in  claim 1 , wherein said lyophilized activated platelet and plasma concentrate results from the inclusion of an agonist to activate a platelet and plasma concentrate.  
     
     
         6 . A wound healant described in  claim 5 , wherein said agonist is selected from the group consisting of thrombin, glass, collagen, serotonin, adenosine diphosphate (ADP) and acetylcholine (ACH), and combinations thereof.  
     
     
         7 . A wound healant described in  claim 1 , wherein said growth factors are included within concentrated platelets and plasma, and said activation results from the inclusion of thrombin and the act of lysine as a result of Lyophilization.  
     
     
         8 . A wound healant described in  claim 7 , wherein said concentrated platelets are autologous or homologous concentrated platelets and having a white blood cell count of below about 3 time 10.sup.7 cells/ml.  
     
     
         9 . A wound healant composition comprising a therapeutically effective amount of concentrated Lyophilized platelets, plasma and/or growth factors and/or thrombin.  
     
     
         10 . A wound healant composition comprising a therapeutically effective amount of concentrated Lyophilized platelets, plasma, at least one anti-oxidant and thrombin.  
     
     
         11 . A wound healant composition described in  claim 10 , wherein said anti-oxidant comprises a retinoid, vitamin E, C, A or beta-carotene.  
     
     
         12 . A wound healant composition described in  claim 11 , wherein said retinoid is vitamin A.  
     
     
         13 . A wound healant composition comprising a therapeutically effective amount of concentrated Lyophilized platelets, plasma, at least one antibiotic and thrombin.  
     
     
         14 . A wound healant described in  claim 13 , wherein said antibiotic is bacteriocidal to at least Pseudomonas and Klebsella bacteria.  
     
     
         15 . A wound healant described in  claim 14 , wherein said antibiotic is selected from the group consisting of a neosporin, vancomycin and gentamycin, and combinations thereof  
     
     
         16 . A wound healant composition comprising a therapeutically effective amount of concentrated Lyophilized platelets, plasma, and GHK-Cu produced by ProCyte Inc. of Seattle, Wash.  
     
     
         17 . A wound healant composition comprising concentrated lyophilized platelets, plasma, at least one retinoid, at least one antibiotic bacteriocidal to at least Pseudomonas and Klebsella and thrombin.  
     
     
         18 . A wound healant composition comprising concentrated platelets in an amount ranging between about 250,000 and about 2.times. 10.sup.9 cells/ml, vitamin C, thrombin in an amount ranging between about 100 U and about 10,000 U, preferably about 900 U and about 1100 U, most preferably about 1000 U per 10 cc of platelet concentrate and calcium chloride in an amount ranging between about 0.1 mg/ml and about 10 mg/ml. Or passed through a piece of glass (i.e. glass wool or glass beads both uncoated).  
     
     
         19 . A wound healant composition as described in  claim 18 , further comprising vitamin A and vitamin E in effective anti-oxidative amounts.  
     
     
         20 . A method of making a wound healant composition, comprising the steps of mixing, in therapeutically effective amount(s), activated Lyophilized platelet and plasma concentrate.  
     
     
         21 . A method of making a wound healant described in  claim 20 , wherein said activated Lyophilized platelet and plasma concentrate are obtained from a blood bank or collection center or Apheresis and mixing thrombin with said platelets.  
     
     
         22 . A method of making a wound healant described in  claim 20 , said method further comprising, either prior to or after Lyophilization and mixing at least one retinoid in sufficient amount(s) to further enhance wound healing.  
     
     
         23 . A method of making a wound healant described in  claim 20 , said method further comprising, prior to mixing said thrombin, mixing at least one antibiotic in sufficient amount(s) to reduce infection by bacteria.  
     
     
         24 . A method of making a wound healant described in  claim 23 , wherein said antibiotic is at least bacteriocidal to Pseudomonas and Klebsella bacteria.  
     
     
         25 . A method of making a wound healant described in  claim 23 , wherein said antibiotic is selected from the group consisting of neosporin, vancomycin and gentamycin, and combinations thereof.  
     
     
         26 . A method of making a wound healant, comprising the steps of, prior to or after Lyophilization, admixing, in therapeutically effective amount(s), concentrated platelets, ascorbic acid, at least one retinoid and at least one antibiotic bacteriocidal to at least Pseudomonas and Klebsella bacteria.  
     
     
         27 . A method of making a wound healant composition, comprising the steps of: extracting blood from a patient, through Apheresis said blood until the appearance of an essentially separate of plasma, an essentially separate of red blood cells, and an essentially intermediate grouping comprised of concentrated platelets and plasma there between; removing said plasma band; centrifuging said remaining blood components at said speed an sufficient duration; removing said concentrated platelets; and mixing, in therapeutically effective amount(s), said concentrated platelets with plasma and thrombin and then Lyophilizing either before adding thrombin or after adding thrombin.  
     
     
         28 . A wound healant prepared in accordance with claims  20 - 27 .  
     
     
         29 . A wound healant prepared in accordance with  claim 26 .  
     
     
         30 . A wound healant prepared in accordance with  claim 27.