Determining IIDP Minimal Donor Criteria
Integrated Islet Distribution Program
Cadaver Donor Criteria
islets
human islets
islet isolation
pancreas
human cadaveric pancreata
Integrated Islet Distribution Program
IIDP
Organ Donor Criteria
Abstract
This SOP defines the pancreas donor profile acceptable for use in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored research in the Integrated Islet Distribution Program (IIDP). This SOP applies to all IIDP islet distribution centers using funds from the NIDDK to manufacture purified human pancreatic islets for basic research studies for IIDP approved investigators.
The IIDP depends on the subcontracted human islet isolation centers to provide research investigators with human islets. It is the responsiblity of the human islet centers to obtain research quality pancreata from the Organ Procurement Organizations (OPO). Some
The donor criteria also reflects the required 2020 testing for COVID-19. Positive testing for COVID-19, HIV, Hepatitis C, and Hepatitis B are examples of some exclusion criteria.
References (attached)
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Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service Guideline, 2020 (Click on hyperlink pop-up)
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optn_policies 3_17_23.pdf Policies - OPTN (hrsa.gov); Policy 2, 5, 11 (Click on hyperlink pop-up or pdf)
Steps
I. IIDP Donor Inclusion Criteria
The following are IIDP Inclusion Criteria for Pancreas Donors for Human Islet Isolation:
A multi-organ donor or pancreas-only donor if the donor meets all the criteria for multi-organ donation
Adequate in situ hypothermic perfusion using UW or similar organ preservation solution for perfusion and cold storage
Maximum 18-hour cold ischemia
Donor age of 0 years to 75 years (no minimum age)
Duration of life support < 14 days
Warm ischemia / Down time < 60 minutes (including cardiac arrests)
Body Mass Index (BMI) of 10-50 kg/m2
II. General Donor Preclusions / Exclusions
The following are frequently encountered disease states or other conditions which constitutes rejection of a potential donor:
Clinical or active viral Hepatitis (A, B, or C)
Malignancies except primary brain tumors or non-melanoma of the skin
Serious illness of unknown etiology as the cause of death
EBV IgM positive
CMV IgM positive
Toxoplasma Immunoglobulin G (IgG) positive
COVID 19 (Sars-CoV-2 test) positive active infection at time of donation (As of May 1, 2020 the IIDP is requiring negative testing for COVID-19 for all IIDP pancreas donors)
- Evidence of previous positive donor COVID-19 testing >28 days, prior to negative testing at time of donation, is acceptable
Acquired Immunodeficiency Syndrome (AIDS)
HIV seropositivity (HIV-I or HIV-II)
Syphilis
Active viral encephalitis or encephalitis of unknown origin
Creutzfeldt–Jacob Disease
Rabies
Recently treated (last 2 years) or active Tuberculosis
Untreated septicemia
III. Public Health Services Guidelines Assessing Solid Organ Donors
The following are the revised recommendations:
People who have had sex with a person known or suspected to have HIV, HBV, or HCV infection in the preceding 3 months
People who have been incarcerated (confinement in jail, prison, or a juvenile correctional facility) for >72 consecutive hours in the preceding 3 months
Men who have had sex with men (MSM) in the preceding 3 months
A person with unknown medical or social history
People who have had sex in exchange for money or drugs in the preceding 3 months
People who have had sex with a person who had sex in exchange for money or drugs in the preceding 3 months
People who injected drugs for non medical reasons.
People who have had sex with a person who injected drugs by intravenous, intramuscular, or subcutaneous route for nonmedical reasons in the preceding 3 months
A child born to a mother with HIV, HBV, or HCV infection
A child breastfed by a mother is known to be infected with HIV infection
IV. Minimum IIDP Donor Criteria List
Attached is a condensed list of the Donor Criteria.
V. Donor Information Forms
A copy of the Donor Information Form, including Serology Test results, Medical and Social History, Consent Form, and OR Management Sheets should be received, with the pancreas or by fax, before the Center's start processing however this information does not need to be provided to IIDP
