Policies & Precautions

Policies

• IIDP Policies and Procedures
• Policy for Crediting Islet Subscription
• Minimal IIDP Criteria for Accepting Human Cadaveric Pancreata for Islet Isolation

Precautions

• The 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings

Information for Investigator IRB Approval

• The human islets that are distributed by the IIDP are from approved cadaveric organ donors from which at least one other organ has been approved for transplantation. Because the donors are brain dead, the IRB’s from the institutions that isolate the islets consider the tissue as “Exempt” from Human Studies Approval. Also, because we only procure from transplant donors, all testing is done prior to donation to assure that the tissue is safe and free of communicable disease. However we recognize that some unknown virus could be present so we do actively warn all of our investigators to use Universal Precautions when handling IIDP islets.

Documents

• Islet Counting Manual
• Islet Handling Tips

IIDP Protocols

Flash Freezing Unclaimed Islets

• Flash Freezing Unclaimed Islets (protocols.io)
• SHP-002 Flash Freezing Unclaimed Islets (Original Edition)
• • Attachment 1-Supply List
  • Attachment 2-Flash Frozen Log Sheet

Standardized International Shipping Documentation

• SHP-003 Standardized International Shipping Documentation (Original Edition)
• • Attachment 1-Fedex Shipping Label
  • Attachment 2-Commercial Invoice
  • Attachment 3-Declaration of Biological Shipments (Fillable)
  • Attachment 4-Commercial Invoice (Fillable)

Culture and Preparation for Cold Shipping

• Culture and Preparation for Cold Shipping (protocols.io)
• SHP-004 Culture and Preparation for Cold Shipping (Original Edition)
• • Attachment 1-Ciprofloxacin Stock Preparation

Cold Shipping of Human Islets

• Cold Shipping of Human Islets (protocols.io)
• SHP-005 Cold Shipping of Human Islets (Original Edition)
• • Attachment 1-Tips for Determining Islet Quality for Shipment
  • Attachment 2-Tips for Efficiency in Packaging
  • Attachment 3-Packaging Islets for IIDP Cold Shipping Demonstration
  • Attachment 4-TipTemp Handling Instructions (Cold Chain Complete)
  • Attachment 5-Ciprofloxacin Stock Preparation

Packaging and Cold Shipping of Non- Islet Pancreatic (Acinar) Tissue (NIPT)

• Cold Shipping of Fresh Non-Islet Pancreatic (Acinar)Tissue (protocols.io)
• SHP-006 Packaging and Cold Shipping of Non- Islet Pancreatic (Acinar) Tissue (Original Edition)
• • Attachment 1-Tips for Efficiency in Packaging
  • Attachment 2-TipTemp Handling Instructions
  • Attachment 3-Ciprofloxacin Stock Preparation
  • Attachment 4-Trypsin Stock Preparation

Packaging and Shipping of Flash Frozen Non-Islet Pancreatic (Acinar) Tissue (NIPT)

• Packaging and Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue (protocols.io)
• SHP-007 Packaging and Shipping of Flash Frozen Non- Islet Pancreatic (Acinar) Tissue (Original Edition)
• • Attachment 1-Ciprofloxacin Stock Preparation
  • Attachment 2-Trypsin Stock Preparation

Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)

• Qualitative & Quantitative Assessment of Human Islets for Distribution Using Dithizone (DTZ) V.4 (protocols.io)
• QA-001 Qualitative & Quantitative Assessment of Human Islets for Distribution Using Dithizone (DTZ)
• • Attachment 1-Work Sheet for Counting
  • Attachment 2-Islet Ranking Guide
  • Attachment 3-Excel Counting Sheet

Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)

• Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI) (protocols.io)
• • Attachment 1Attachment 1- Preparation of Fluorescein Diacetate and Propidium Iodide Stock Solutions (FDA/PI) (protocols.io)
• QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI) (Original Editition)
• • Attachment 1-Preparation Fluorecein Diacetate and Propidium Iodide Solutions
  • Attachment 2-Viability Estimation of Islets for Distribution Using Fluorescent Dyes, Islets Viability Worksheet

Microbiology Testing for Islets for Distribution

• QA-003 Microbiology Testing for Islets for Distribution
• • Attachment 1-Microbiology Tracking Worksheet

Sentinel Flask Preparation

• Sentinel Flask Preparation for Cold Shipping Protocol of Human Islets (protocols.io)
• QA-004 Sentinel Flask Preparation (Original Edition)
  • Attachment 1-Qualitative Sentinel Flask Documentation Sheet

Potency Test: Glucose Stimulated Insulin Release Assay

• Potency Test: Glucose Stimulated Insulin Release Assay (protocols.io)
• QA-005 Potency Test: Glucose Stimulated Insulin Release Assay (Original Edition)
  • Attachment 1-Solutions preparation Sheets
  • Attachment 2-Microtiter Plate Layout
  • Attachment 3-GSIR Worksheet

Uploading of Digital Image of Count Sample

• QA-006 Acquisition and Uploading of Digital Image of Count Sample for Broadcast

Preparing Pancreas Section for Histology

• QA-007 Preparing Pancreas Section for Histology
• • Attachment 1-Histology Log Sheet

Minimal IIDP Criteria for Accepting Human Cadaveric Pancreata for Islet Isolation

• Determining IIDP Minimal Donor Criteria (protocols.io)
• QA-008 Determining IIDP Minimal Donor Criteria (Original Edition)

IIDP Center Islet Isolation Protocols

Scharp Lacy Institute

• Advances in Human Islet Processing: Manufacturing Steps to Achieve Predictable Islet Outcomes from Research Pancreases

Southern California Islet Cell Resource Center

• National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
• Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428

University of Miami

• National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
• Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428

University of Pennsylvania

• National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
• Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428

University of Wisconsin

• National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
• Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428