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

SHP-002 Flash Freezing Unclaimed Islets

• SHP-002 Flash Freezing Unclaimed Islets
• • Attachment 1-Supply List
  • Attachment 2-Flash Frozen Log Sheet
  • Attachment 3-Flash Frozen Inventory, Broadcasting Staff User’s Guide
  • Attachment 4-Flash Frozen Inventory, Investigator User’s Guide

SHP-003 Standardized International Shipping Documentation

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

SHP-004 Culture and Preparation for Cold Shipping

• SHP-004 Culture and Preparation for Cold Shipping
• • Attachment 1-Ciprofloxacin Stock Preparation

SHP-005 Cold Shipping of Human Islets

• SHP-005 Cold Shipping of Human Islets
• • Attachment 1-Tips for Determining Islet Quality for Shipping
  • Attachment 2-Tips for Efficiency in Packaging
  • Attachment 3-Packaging Islets for Cold Shipping Demonstration
  • Attachment 4-Tip Temp Handling Instructions
  • Attachment 5-Ciprofloxacin Stock Preparation

SHP-006 Cold Shipping of Fresh Non-Islet Pancreatic (Acinar)Tissue

• SHP-006 Cold Shipping of Fresh Non-Islet Pancreatic (Acinar)Tissue
• • Attachment 1-Tips for Efficiency in Packaging
  • Attachment 2-Storage and Prep
  • Attachment 3-Ciprofloxacin Stock Preparation

SHP-007 Cold Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue

• SHP-007 Cold Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue

QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)

• QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)
• • Attachment 1-Counting Worksheet
  • Attachment 2-Islet Ranking Guide
  • Attachment 3-Editable Counting Work-Sheet

QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)

• QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)
• • Attachment 1-Preparation Fluorecein Diacetate and Propidium Iodide Solutions
  • Attachment 2-Islet Viability Worksheet

QA-003 Microbiology Testing for Islets for Distribution

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

QA-004 Sentinel Flask Preparation

• QA-004 Sentinel Flask Preparation
• • Attachment 1-Sentinel Flask Preparation

QA-005 Potency Test: Glucose Stimulated Insulin Release Assay

• QA-005 Potency Test: Glucose Stimulated Insulin Release Assay
• • Attachment 1-Solution Preparation Sheets
  • Attachment 2-Microtiter Plate Layout
  • Attachment 3-GSIR Worksheet

QA 006 Uploading of Digital Image of Count Sample

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

QA 007 Preparing Pancreas Section for Histology

• QA-007 Preparing Pancreas Section for Histology
• • Attachment 1-Histology Log Sheet
  • Attachment 2-FedEx Reimbursement Invoice Template

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