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Overview
Program History
IIDP and HIPP Team
Advisors
Program Statistics
Program Sponsor
Announcements
Mission Statement
Newsletters
Centers
Islet Isolation Center Contact Information
Frequently Asked Questions
Policies & Standard Operating Procedures
Center Login
Investigators
Our Services
Islet Award Initiative
Frequently Asked Questions
Policies & Standard Operating Procedures
Investigator Login
Helpful Hints for Human Islets
Publications
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Policies & Standard Operating Procedures
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Policies & Standard Operating Procedures
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 1
Attachment 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