Human Amniotic Membrane Lyophilized Grafts

Inactive Publication Date: 2014-07-03
ALPHA TISSUE
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  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0009]Described herein are human tissue grafts derived from the placenta comprised of the amniotic membrane which is processed using physiologic solutions, lyophilization and terminal sterilization (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. The advantage of this invention is that it solves the probl

Problems solved by technology

There are storage challenges with the amniotic membrane in the cryopreserved fo

Method used

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  • Human Amniotic Membrane Lyophilized Grafts
  • Human Amniotic Membrane Lyophilized Grafts

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[0013]First it is to be understood that the aspects of the methods to be described are not limited to specific compounds, exact methods described or uses as such may vary. FIG. 1 depicts a process overview flowchart for the recovery and manufacture of the tissue grafts described herein.

[0014]Step 1: Informed Consent Obtained, Donor Pre-Screened for Eligibility and Suitability

[0015]Initially, the potential female donor is approached and written informed consent is obtained following standard industry practices and the guidelines set forth by AATB. The potential donor must fully understand the donation process and give their informed consent to the process and to the testing of their blood for diseases that may affect the suitability of their placenta tissues for use.

[0016]After written consent is obtained, the donor is pre-screened for eligibility and suitability to donate her placenta at delivery. Screening involves assessment for risk factors to communicable diseases as specified i...

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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...

Claims

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Application Information

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IPC IPC(8): A61K35/50A61F2/02
CPCA61F2/02A61K35/50A61L27/3604A61L27/3641A61L27/3662A61L27/3679A61L27/3691A61L27/507A61L27/60A61L2430/10A61L2430/34C12N5/0605
Inventor BROUSSARD, TERRY W.
Owner ALPHA TISSUE
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