Molded placental tissue compositions and methods of making and using the same

Patent metadata

Field	Value
Publication number	US-10029030-B2
Application number	US-201313815753-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Mar 15, 2013
Publication date	Jul 24, 2018
Grant date	Jul 24, 2018

Abstract

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.

First claim

What is claimed is:

1. A method for enhancing wound healing, the method comprising applying a placental tissue composition at or near the site of the wound; wherein said composition has a defined size and shape; wherein said composition comprises micronized amnion, and optionally one or more of micronized amnion, micronized chorion, micronized intermediate tissue layer, and any combination thereof; wherein at least one of the micronized amnion comprises a fibroblast cell layer; when said composition is molded and dehydrated; wherein said composition is not cross-linked and has a sufficient density and cohesiveness to maintain its size and shape for a defined period of time ex vivo and in vivo; and wherein the density is from 1.2 g/cm 3 to 10 g/cm 3 .

2. The method of claim 1 , wherein the composition is administered sub-cutaneously, sub-dermally, intramuscularly, or at the periosteal interface.

3. The method of claim 1 , wherein the composition is a pharmaceutical composition.

4. The method of claim 3 , said pharmaceutical composition further comprising a pharmaceutically acceptable excipient.

5. The method of claim 1 , wherein the water content of the composition is less than 15%.

6. The method of claim 1 , wherein the water content of the composition is less than 10%.

7. The method of claim 1 , wherein the water content of the composition is less than 5%.

8. The method of claim 1 , wherein the micronized amnion, micronized chorion, micronized intermediate tissue layer, or any combination thereof has a particle size of less than 350 μm.

9. The method of claim 1 , wherein the micronized amnion, micronized chorion, micronized intermediate tissue layer, or any combination thereof has a particle size of less than 300 μm.

10. The method of claim 1 , wherein the water content of the composition is less than 20%.

11. The method of claim 1 , wherein the micronized amnion, micronized chorion, micronized intermediate tissue layer, or any combination thereof has a particle size of less than 400 μm.

12. A method for enhancing wound healing, the method comprising applying a placental tissue composition at or near the site of the wound, wherein said composition has a defined size and shape; wherein said composition consists of micronized amnion wherein the micronized amnion comprises a fibroblast cell layer; wherein said composition is molded and dehydrated; and wherein said composition is not cross-linked and 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 .

13. The method of claim 12 , wherein the composition is a pharmaceutical composition.

14. The method of claim 12 , wherein the water content of the composition is less than 20%, less than 15%, less than 10%, or less than 5%.

15. The method of claim 12 , wherein the micronized amnion has a particle size of less than 400 um, less than 350 um, or less than 300 um.

Assignees

• Mimedx Group Inc

Inventors

• Koob Thomas J
• Denoziere Guilhem
• Brown Rebeccah J C

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P17/02

  for treating wounds, ulcers, burns, scars, keloids, or the like · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title

• A61L27/3604 Primary

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61L27/3695

  characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this (A61L27/3687, A61L27/3691 take precedence) · CPC title