AmgraftTM allografts are procured and processed according to standards established by the American Association of Tissue Banks (AATB) and the United State Food and Drug Administration (FDA). All tissues are recovered under full unformed consent of the planned c-section donors (represented by the mothers of the newborn children) The donors have consented to transfer of the the allografts to third parties. A thorough medical exam and social history of the donor is also obtained, including detailed family history.