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Amniotic Membrane Powder and Methods of Making

Inactive Publication Date: 2014-11-20
WAKE FOREST UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is a composition that induces wound healing and tissue regeneration. The composition includes amniotic membrane, which is a natural material derived from a mammal, such as a human. The amniotic membrane can be in the form of a powder or a solubilized amniotic membrane. The composition can also include a scaffold, which is a hydrogel or a synthetic polymer. The scaffold can be bioprinted or applied directly to the treatment site. The composition can be applied to the surface of a dressing or can be injected into the body. The technical effects of the invention include promoting wound healing and tissue regeneration, providing a natural material for wound healing, and inducing stem cell differentiation.

Problems solved by technology

Extensive burns and full thickness skin wounds can be devastating to patients, even when treated.
In particular, burn patients who receive delayed treatments often are subject to extensive scarring that can result in negative long-term physiological effects.
While this treatment yields a reasonable clinical outcome, if the wound is extensive, then the number and size of donor sites are limited.
These limitations have thus led to the development of non-cellular dermal substitutes, which are most often comprised of a polymeric scaffold.
Examples include Integra and Biobrane, and although such materials result in improved wound healing when compared with untreated controls (Lesher et al., 2011, J Pediatr Surg, 46: 1759-1763; Rahmanian et al., 2011, Burns, 37: 1343-1348), they are costly to produce and result in relatively poor cosmetic outcomes.
Unfortunately, these grafts are also expensive to produce, and similar to allografts, have the same immunological drawbacks discussed elsewhere herein.
However, autologous and allogenic keratinocytes suffer from the same drawbacks as their autologous and allogenic skin graft counterparts; i.e. secondary surgical sites and potential for rejection, respectively.
Furthermore, cell therapies have complicated regulatory and financial hurdles to overcome prior to commercialization.

Method used

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  • Amniotic Membrane Powder and Methods of Making
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Examples

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experimental examples

[0175]The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.

[0176]Without further description, it is believed that one of ordinary skill in the art may, using the preceding description and the following illustrative examples, make and utilize the compounds of the present invention and practice the claimed methods. The following working examples therefore, specifically point out the preferred embodiments of the present invention, and are not to be construed as limiting in any way the remainder of the disclosure.

example 1

Solubilized Amniotic Membrane (SAM) Containing Hydrogel

[0177]Experiments were designed to create a wound healing product with high clinical efficiency, and preferably one that does not require a cellular component, yet retains the bioactivity of a cellular treatment.

[0178]Amniotic membrane patches have been implemented as dressings for skin wounds for many years. However, application of freeze-dried or cryopreserved patches (amnion-based or artificial grafts as described above) is not optimal for the many wounds that are irregularly-shaped and / or variable depth. To address this problem, a protocol for solubilizing amniotic membrane samples to produce a solubilized amniotic membrane (SAM) solution which can be combined with a number of materials for deposition over wounds was developed. SAM is a cell-free solution, containing cytokines, extracellular matrix (ECM) ECM-associated proteins and other factors that are known to promote wound healing and modulate inflammatory responses. The...

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Abstract

The present invention provides compositions and methods for wound healing and tissue regeneration. The compositions of the present invention comprise amniotic membrane of the placenta. In certain embodiments, the composition comprises amniotic membrane powder or solubilized amniotic membrane (SAM). In some aspects, the composition is cell-free and rich in cytokines, extracellular matrix proteins, and other components that improve tissue regeneration. In one aspect, the composition is a hydrogel scaffold that comprises amniotic membrane. The present invention reduces contraction and improves blood vessel development in regenerating tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is entitled to priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application 61 / 698,960, filed Sep. 10, 2012, the content of which is incorporated by reference in its entirety herein.BACKGROUND OF THE INVENTION[0002]Extensive burns and full thickness skin wounds can be devastating to patients, even when treated. There are an estimated 500,000 burns treated in the United States each year (Chemy et al., 2008, Natl Health Stat Report: 1-39; Pitts et al., 2008, Natl Health Stat Report: 1-38). The overall mortality rate for burn injury was 4.9% between 1998-2007 and medical costs for burn treatments approach $2 billion per year (Miller et al., 2008, J Burn Car Res, 29: 862-871). Globally, this statistic increases to 11 million injuries per year (Peck, 2011, Burns, 37: 1087-1100). In addition to burns, full-thickness chronic wounds constitute a large patient base, and despite technological advancement of treatm...

Claims

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Application Information

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IPC IPC(8): A61K35/50
CPCA61K35/50A61L27/34A61L27/48A61L27/52A61L15/40A61L26/0057A61L26/0076A61L2430/40C12N5/0068C12N2533/92A61L27/3604A61L27/3683C08L89/00A61K47/36A61K47/42
Inventor MURPHY, SEAN V.SKARDAL, ALEKSANDERATALA, ANTHONY
Owner WAKE FOREST UNIVERSITY
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