Amniotic Membrane Powder and Methods of Making

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...

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.

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