Molded placental tissue compositions and methods of making and using the same
Described herein are molded dehydrated placental tissue compositions, and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the molded dehydrated placental tissue compositions are also described herein.
1. A molded, compressed, dehydrated placental tissue composition having a defined size and shape wherein said molded dehydrated placental tissue composition consists essentially of washed, cleaned, micronized amnion, and optionally one or more of washed, cleaned, micronized chorion, intermediate tissue layer, additional amnion, and any combination thereof, wherein at least one of the amnion comprises a fibroblast cell layer, and wherein said composition has a sufficient density and cohesiveness to maintain its size and shape for a defined period of time ex vivo and in vivo, wherein the density of the composition is from 1.2 g/cm 3 to 10 g/cm 3 ; and wherein the water content of the composition is less than 5%.
2. The composition of claim 1 , wherein the micronized amnion, chorion, intermediate tissue layer, and any combination thereof has a particle size of less than 400 μm.
3. The composition of claim 1 , wherein at least one of the amnion, chorion, intermediate tissue layer, or any combination thereof are cross-linked.
4. A pharmaceutical composition comprising the composition of claim 1 and optionally a pharmaceutically acceptable excipient.
5. The composition of claim 1 , wherein the micronized amnion, chorion, intermediate tissue layer, and any combination thereof has a particle size of less than 350 μm.
6. The composition of claim 1 , wherein the micronized amnion, chorion, intermediate tissue layer, and any combination thereof has a particle size of less than 300 μm.
7. A molded, compressed, dehydrated placental tissue composition having a defined size and shape, wherein said composition consists of washed, cleaned, micronized amnion wherein the amnion comprises a fibroblast cell layer, wherein said composition has a sufficient density and cohesiveness to maintain its size and shape for a defined period of time ex vivo and in vivo wherein the density is from 1.2 g/cm 3 to 10 g/cm 3 ; and wherein the composition has a water content which is less than 5%.
8. The composition of claim 7 , wherein the micronized amnion has a particle size of less than 400 μm.
9. The composition of claim 7 , wherein the micronized amnion has a particle size of less than 350 μm.
10. The composition of claim 7 , wherein the micronized amnion has a particle size of less than 300 μm.
11. A molded, compressed, dehydrated placental tissue composition having a defined size and shape, wherein said composition consists of washed, cleaned, micronized amnion and washed, cleaned, micronized chorion, wherein the amnion comprises a fibroblast cell layer, wherein said composition has a sufficient density and cohesiveness to maintain its size and shape for a defined period of time ex vivo and in vivo wherein the density is from 1.2 g/cm 3 to 10 g/cm 3 ; and wherein the composition has a water content which is less than 5%.