Birth tissue material and method of preparation

Abstract

A placental construct for treatment of a disease or condition is provided. The placental construct includes a therapeutically effective amount of a birth tissue material.

We claim: 
     
         1 . A placental construct for treatment of a disease or condition, the placental construct comprising a therapeutically effective amount of a birth tissue material, wherein the birth tissue material comprises
 at least one morselized placental tissue component; and   an amniotic fluid composition.   
     
     
         2 . The placental construct of  claim 1 , wherein the at least one placental tissue component is amniotic membrane. 
     
     
         3 . The placental construct of  claim 1 , wherein the placental construct is used for bone or soft tissue repair, bone or soft tissue reconstruction, bone or soft tissue augmentation, bone or soft tissue sealing, or soft tissue cosmetic applications. 
     
     
         4 . The placental construct of  claim 1 , wherein the disease or condition is a soft tissue defect or a bone void. 
     
     
         5 . The placental construct of  claim 4 , wherein the soft tissue defect is a persistent wound selected from the group consisting of diabetic ulcer, decubitus ulcer, venous leg ulcer, arterial leg ulcer, and cutaneous ulcer. 
     
     
         6 . The placental construct of  claim 4 , wherein the soft tissue defect is tendinitis or tendinosis. 
     
     
         7 . The placental construct of  claim 1 , wherein the placental construct is applied directly into or onto a site to treat a soft tissue defect or bone void. 
     
     
         8 . The placental construct of  claim 1 , wherein the construct is in an injectable formulation. 
     
     
         9 . The placental construct of  claim 1 , wherein the birth tissue material is cryopreserved prior to use. 
     
     
         10 . The placental construct of  claim 1 , wherein the construct further comprises one or more structural carriers selected from the group consisting of an amniotic membrane and/or chorionic membrane, a soft tissue allograft, a bone allograft, and platelet rich plasma. 
     
     
         11 . The placental construct of  claim 1 , wherein the construct further comprises one or more bioactive agents selected from the group consisting of physiologically compatible minerals, growth factors, antibiotics, chemotherapeutic agents, antigens, antibodies, enzymes, vectors for gene delivery, and hormones. 
     
     
         12 . A placental construct for treatment of a disease or condition, the placental construct comprising a therapeutically effective amount of a birth tissue material prepared by a process comprising the steps of:
 (a) recovering placental tissue components and amniotic fluid from a seronegative, healthy human via cesarean section or vaginal delivery;   (b) subjecting the placental tissue components to cryopreservation;   (c) morselizing the cryopreserved placental tissue components;   (d) homogenizing the morselized placental tissue components in a tissue suspension solution to form a tissue suspension;   (e) homogenizing the tissue suspension with an amniotic fluid composition to form a bulk tissue product; and   (f) cryofreezing the bulk tissue product to form the human birth tissue material.   
     
     
         13 . A placental construct for treatment of a disease or condition, the placental construct comprising a therapeutically effective amount of a birth tissue material, wherein the birth tissue material comprises
 a tissue suspension comprising morselized placental tissue components homogenized in a tissue suspension solution; and   an amniotic fluid composition comprising a cell suspension solution.   
     
     
         14 . The placental construct of  claim 13 , wherein the tissue suspension solution comprises Plasma Lyte-A, human albumin solution, and dimethyl sulfoxide. 
     
     
         15 . The placental construct of  claim 13 , wherein the tissue suspension solution comprises about 44% volume of Plasma Lyte-A, about 36% volume of human albumin 25% solution, and about 20% volume of dimethyl sulfoxide. 
     
     
         16 . The placental construct of  claim 13 , wherein the cell suspension solution comprises Plasma Lyte-A and human albumin solution. 
     
     
         17 . The placental construct of  claim 13 , wherein the cell suspension solution comprises about 91% volume of Plasma Lyte-A and about 9% volume of human albumin 25% solution. 
     
     
         18 . A kit comprising at least one placental construct of  claim 1  and at least one additional structural carrier. 
     
     
         19 . The kit of  claim 18 , wherein the structural carrier is selected from the group consisting of placental membrane construct, soft tissue allograft, bone allograft, and platelet rich plasma. 
     
     
         20 . The kit of  claim 18 , further comprising instructions for use thereof.