May 25, 2023

Public workspaceADI IsletCore Minimal Donor Criteria V.2

DOI
dx.doi.org/10.17504/protocols.io.14egn2p7mg5d/v2
  • 1University of Alberta
Jocelyn E Manning Fox
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DOI: dx.doi.org/10.17504/protocols.io.14egn2p7mg5d/v2
External link: http://www.bcell.org/adi-isletcore
Protocol Citation: Jocelyn E Manning Fox, James Lyon, Patrick MacDonald 2023. ADI IsletCore Minimal Donor Criteria. protocols.io https://dx.doi.org/10.17504/protocols.io.14egn2p7mg5d/v2Version created by Jocelyn E Manning Fox
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 25, 2023
Last Modified: May 25, 2023
Protocol Integer ID: 82488
Keywords: Donor criteria, Exclusion criteria, Human pancreas, IsletCore
Abstract
This SOP defines the pancreas donor profile acceptable for use by the Alberta Diabetes Institute IsletCore in their human islet isolation program.

ADI IsletCore receives pancreases from multiple Canadian Organ Procurement Organizations (OPO). The OPO reports anonymized donor information and serology results to ADI IsletCore. Informed consent for research use of the pancreas is obtained and held on record by the relevant OPO.

Guidelines
Responsibilities
  • This SOP applies to the Alberta Diabetes Institute IsletCore.

  • It is the responsibility of ADI IsletCore staff to both follow and ensure adherence to the donor criteria outlined in this SOP prior to acceptance of a pancreas

  • It is the responsibility of the ADI IsletCore staff to ensure that information relating to the donor is provided by the Organ Procurement Organization (OPO), and that this is accurately recorded in IsletCore’s database, and the accompanying paperwork is filed securely.
Abbreviations
  • ADI: Alberta Diabetes Institute

  • SOP: Standard Operating Procedures

  • NDD: neurological determination of death.

  • DCD: Donation after cardiocirculatory death.

  • MAID: Medical assistance in dying.

  • HbA1c: Hemoglobin A1c.

  • CPR: Cardiopulmonary resuscitation.

  • HIV: Human immunodeficiency virus

  • HTLV: Human T-lymphotropic virus

  • HBsAg: Hepatitis B surface antigen

  • Anti-HBc: Hepatitis B core antigen

  • Anti-HCV: Anti Hepatitis C antibodies

  • NAT HIV: Nucleic acid test human immunodeficiency virus

  • NAT Hep C: Nucleic acid test hepatitis C

  • SARS CoV-2: Virus causing COVID-19


Acknowledgments:

We thank the Organ Procurement Organizations, including Human Organ Procurement and Exchange (HOPE) program and Trillium Gift of Life Network (TGLN), for their work in procuring human donor pancreas for research. We especially thank the organ donors and their families for their kind gift in support of diabetes research.
ADI IsletCore Donor Inclusion Criteria
ADI IsletCore Donor Inclusion Criteria
The following are ADI IsletCore inclusion criteria for pancreas donors for human islet isolation:

  1. A multi-organ donor or pancreas-only donor if the donor meets all the criteria for multi-organ donation
  2. Any type of donation (NDD, DCD, MAID)
  3. DCD warm ischemia time <30 minutes
  4. Adequate in situ hypothermic perfusion using UW or similar organ preservation solution for perfusion and cold storage
  5. Maximum 24 hour cold ischemia
  6. Donor age of 0 years to 100 years (no minimum age)
  7. Any donor body mass index (BMI)
  8. Any donor HbA1c
  9. Any donor diabetes status (no diabetes, Type 1 diabetes, Type 2 diabetes, other types of diabetes)
  10. Peak amylase between 40 to 140 units per litre (no data also acceptable)
  11. Peak lipase between 0 to 160 units per litre
  12. Duration of life support < 14 days
  13. Warm ischemia / Down time < 60 minutes (including CPR)
General Donor Preclusions / Exclusions
General Donor Preclusions / Exclusions
The following represent disease states or other conditions that are criteria for rejection of a potential donor.

  1. Recently treated (last 2 years) or active tuberculosis
  2. Serious illness of unknown etiology as the cause of death
  3. Active viral encephalitis or encephalitis of unknown origin
  4. Creutzfeldt–Jacob Disease
  5. Rabies
  6. Positive test result for any of the following:
  • Anti-HIV 1 & 2
  • Anti-HTLV 1 & 2
  • HBsAg
  • Anti-HBc
  • Anti-HCV
  • Syphilis
  • NAT HIV
  • NAT Hep C
  • Blood culture
  • SARS CoV-2 (evidence of previous positive testing >30 days prior, with negative testing at time of donation, is acceptable)
Additional Criteria
Additional Criteria
Additional exclusion criteria may be applied by procurement surgeons and/or IsletCore staff on a case-by-case basis, following review of donor’s social and medical history, and physical assessment of the pancreas.
Protocol references
Lyon J et al (2016) Research-focused isolation of human islets from donors with and without diabetes at the Alberta Diabetes Institute IsletCore. Endocrinology, 157(2): 560-569.

Lyon J, Spigelman AF, Fox JEM, Macdonald PE. ADI IsletCore Protocols for the Isolation, Assessment and Cryopreservation of Human Pancreatic Islets of Langerhans for Research Purposes. protocols.io https://www.protocols.io/view/adi-isletcore-protocols-for-the-isolation-assessme-bupanvie