May 11, 2022

Public workspaceFemale Reproductive System Deceased Donor and Tissue Eligibility Criteria for Penn TMC

DOI
dx.doi.org/10.17504/protocols.io.4r3l2oe2pv1y/v1
  • 1University of Pennsylvania
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DOI: dx.doi.org/10.17504/protocols.io.4r3l2oe2pv1y/v1
Protocol Citation: Kate O'Neill 2022. Female Reproductive System Deceased Donor and Tissue Eligibility Criteria for Penn TMC. protocols.io https://dx.doi.org/10.17504/protocols.io.4r3l2oe2pv1y/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it’s working
Created: May 10, 2022
Last Modified: May 11, 2022
Protocol Integer ID: 62367
Abstract
This document outlines the required criteria for deceased donor inclusion of the female reproductive system in the Human BioMolecular Atlas Program (HuBMAP) for the University of Pennsylvania Tissue Mapping Center.This protocol was developed and is executed in collaboration with the organ procurement organization the Gift of Life Donor Program.

This study intends to be as inclusive as possible of race and ethnicity.
Gift of Life Donor Program (GLDP) transplant coordinators receive annual training by MPI O’Neill in HuBMAP initiative.
Trained coordinators will evaluate patient for eligibility using criteria detailed in following sections.
Transplant coordinator will call MPI O’Neill to review inclusion/exclusion criteria and confirm sample team availability.
Once MPI O’Neill has confirmed donor meets I/E criteria and sample team is available, LNOK (living next of kin) will be approached by transplant coordinators to obtain authorization for vascularized composite allograft (VCA) donation and use of tissue for research purposes. See Download GLDP VCA Donor Authorization.pdfGLDP VCA Donor Authorization.pdf .

Provided LNOK consents, procurement team will be notified of donor enrollment in HuBMAP and the female reproductive system will be recovered.
Inclusion criteria
Inclusion criteria
  • Authorization for organ and/or tissue donation is signed by living next of kin (LNOK). See Download GLDP Organ Donor Authorization.pdfGLDP Organ Donor Authorization.pdf .
  • Donor has known state of health and diagnoses
  • Donor has non-reactive HIV/HCV/HBV NAT testing documented.
  • Donor has non-reactive HBV surface antigen testing documented.
  • Donor has non-reactive HBC encoded antigen testing documented.
  • Organ donation is after brain death
  • Donor has normal gross Mullerian structures
  • Donor is between the 18-45 years of age

Exclusion criteria
Exclusion criteria
  • Organ donation after cardiac death
  • Pregnancy
  • History of reproductive tract malignancy, endometriosis, significant uterine surgery (specifically myomectomy)
  • Tissue collected >4 hours after clamp time.