METHODS OF PREPARING LYOPHILIZED HUMAN TISSUES

摘要

Described herein are methods of preparing 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 in a frozen state, the graft has the advantage of storage at ambient temperatures for prolonged periods of time prior to transplantation.

主权项

1. A method of preparing a tissue to be a biological dressing or a tissue graft, said method comprising:
cleaning an amniotic membrane having the following layers in the following order:
a) an epithelium layer;b) a basement membrane layer; andc) a stroma layer comprising an upper compact layer, a middle fibroblast layer, and a lower spongy layer; lyophilizing the amniotic membrane after said cleaning; and in a frozen state, terminally sterilizing the amniotic membrane using gamma irradiation.