Human Amniotic Membrane Lyophilized Grafts

Abstract

Described herein are human amniotic membrane tissue grafts derived from the placenta. The grafts are composed of three layers as seen in the amniotic membrane in utero. These grafts are processed using physiologic solutions, lyophilized and terminal sterilized (via gamma irradiation in a frozen state) that thereby preserves the graft in such a manner as to retain the naturally occurring biological properties of the amniotic membrane and offer a sterile graft for transplantation. By dehydration via lyophilization and terminal sterilization, the graft has the advantage of storage at ambient temperatures for prolonged periods of time prior to transplantation.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] Not ApplicableSTATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] Not ApplicableNAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

[0003] Not ApplicableINCORPORATION-BY-REFERENCE OF MATERIAL

[0004] Not ApplicableBACKGROUND OF THE INVENTION

[0005] Human amniotic membrane derived from the placenta has been used for nearly 100 years as a transplantable biomaterial for the surgical reconstruction of various tissues in the human body. Such a membrane has been utilized widely in the management of ocular surface disorders; utilized as a biological dressing or graft for skin (burns, skin wounds, skin ulcers); utilized to prevent tissue adhesion in surgical procedures of the spine, abdomen and pelvis; utilized as a wrap for tendon and nerve repair procedures; and utilized as a graft for dental / oral procedures. Normally, such a membrane has is either dehydrated or cryopreserved prior to storage until ready for surgical transplantation.

[0006] The placent...

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