Internationally Standardized Terminology for Regenerated Tissue

Size: px
Start display at page:

Download "Internationally Standardized Terminology for Regenerated Tissue"

Transcription

1 Internationally Standardized inology for Regenerated Tissue Consultation Document March 2018

2 Internationally Standardized inology for Regenerated Tissue 2 Introduction There is growing recognition of the need for a globally consistent terminology and a coding system to ensure unique identification of medical products of human origin (MPHO) worldwide. This need has been recognized by the World Health Assembly in 2010, and Resolution WHA63.22 urges member states to encourage the implementation of globally consistent coding systems for human cells, tissues and organs as such in order to facilitate national and international traceability of materials of human origin for transplantation. ICCBBA is an international standards organization in the field of transfusion and transplantation and is a nongovernmental organization in official relations with the World Health Organization. ICCBBA has already developed international consensus terminology for a number of MPHO. The Regenerative Medicine Technical Advisory Group (RMTAG) was formed by ICCBBA to develop an internationally standardized terminology for regenerated tissue. The RMTAG, under the chairmanship of first Dr. Ruth Warwick and then Dr. Ineke Slaper- Cortenbach, has developed the terminology proposed in this document. A limited subset of this terminology has been published in the ISBT 128 Standard inology for Medical Products of Human Origin in order to meet urgent needs of ISBT 128 users. However, comments on both this proposal, and the terminology actually in use, are welcome. The terminology presented is open for public comment and the advisory group welcomes constructive criticism. Following the consultation period, final adjustments will be made before formal publication. Background ISBT 128 is a well-established international coding system for MPHO. It provides a comprehensive and highly flexible system for describing products and assigning product codes suitable for use in bar codes and other electronic communication. The foundation of this system is a terminology that is constructed by international consensus to ensure global consistency in use and understanding. The ISBT 128 product description code database is created using a rules-based system. It uses classes and attributes to describe products, and then assigns each product a unique five-character product description code. Classes are broad descriptions of products. For Regenerated Tissue, examples of proposed classes are REGENERATED EPIDERMIS and REGENERATED CARTILAGE. Attributes provide the means to further describe the product. Attributes are arranged in groups, and within each attribute group there are a number of possible variables, only one of which can be selected. For example, Type of Cells is a group; Keratinocytes is a variable within that group. Where a product does not have a variable assigned from a particular group, the default variable for that group will apply. For example, Not Specified, which means The type of cells within the product is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation, is the default for Type of Cells.

3 Internationally Standardized inology for Regenerated Tissue 3 The product code is eight characters long (see Figure 1), with the first five characters comprising the product description code. The first character of this code, letter P in Figure 1, signifies it is a regenerated tissue product. The sixth character indicates the collection type (e.g., voluntary, autologous, directed, designated) and the remaining two characters provide a means to uniquely identify multiple occurrences of a product derived from the same collection event. Thus if two products with the same product description code are created during processing, they can be uniquely identified by using A0 and B0 in these two positions. If more divisions are needed than are supported by the last two characters of the product code, another data structure is used. Figure 1 Product Code Collection For more information, please see the following documents on the ICCBBA website: ISBT 128 Standard Technical Specification (ST-001) ISBT 128 Standard inology for Medical Products of Human Origin (ST-002) Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] Tissues (IG-020) Implementation Guide: Product Coding [Data Structures 003 and 032] Cellular Therapy (IG-022) Implementation Guide: Use of Product Divisions [Data Structure 032] (IG-023)

4 Internationally Standardized inology for Regenerated Tissue 4 Consultation This document is being made publically available on the ICCBBA website, and relevant professional bodies have been notified and asked to bring this to the attention of their stakeholders. Proposed terminology is on the following pages. Additional terms will be added as they are requested by users, and such terminology will follow the same format. As you review the terminology, please consider these questions: 1. Should additional class names be added? If so, what classes should be added? 2. Should additional attribute groups be added? If so, what groups should be added? What should the variables for these groups be? 3. Should additional attribute variables be added to the proposed groups? If so, what should these variables be? Additional comments are also welcome. Feedback should be submitted by May 11, 2018 to the following URL: The advisory group will review all comments prior to finalizing the terminology.

5 Internationally Standardized inology for Regenerated Tissue 5 Regenerated Tissue inology Regenerated tissue would be defined as: Viable cells constructed into a tissue or seeded onto a scaffold. The template used in the ISBT 128 terminology would be the word Regenerated followed by the type of tissue structure. If there is not a specific structure or type of tissue, the term Regenerated Tissue would be used. Proposed Classes: REGENERATED CARTILAGE REGENERATED CORNEAL EPITHELIUM REGENERATED DERMIS REGENERATED ELASTIC CARTILAGE REGENERATED EPIDERMIS REGENERATED FIBROCARTILAGE REGENERATED HYALINE CARTILAGE REGENERATED LIVER TISSUE REGENERATED ORAL MUCOSA REGENERATED SKIN REGENERATED TISSUE REGENERATED TRACHEA Viable cells constructed into cartilage. Viable cells constructed into corneal epithelium. Viable cells constructed into dermis. Viable cells constructed into elastic cartilage. Viable cells constructed into epidermis. Viable cells constructed into fibrocartilage. Viable cells constructed into hyaline cartilage. Viable cells constructed into liver tissue. Viable cells constructed into oral mucosa. Viable cells constructed into skin. Viable cells in a scaffold without a named tissue structure. Viable cells seeded onto a trachea or trachea segment scaffold. Proposed Attribute Groups: Type of Cells Source of Cells Origin of Scaffold Scaffold Degradability Storage Temperature Delivery Method Ancillary Substances Excipients Describes the primary type of cells used to create the product. Specifies the source of the cells. Specifies the origin of the scaffold. (The scaffold is the support for cells enabling a 2-D or 3-D structure.) Specifies whether the scaffold will stay in place or be degraded. Describes the storage temperature range. Describes the form of the product for implantation. Indicates the presence of substances used during the manufacturing of products that may not be entirely removed. Indicates the presence of inactive ingredients that were added during product formulation.

6 Internationally Standardized inology for Regenerated Tissue 6 Proposed Attribute Variables: Type of Cells Group Keratinocytes Chondrocytes Hepatocytes Epithelial Cells Melanocytes Fibroblasts Urothelial Cells MSC Multiple Cell Types The type of cells within the product is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Keratinocytes are the primary cell type present in the product. Chondrocytes are the primary cell type present in the product. Hepatocytes are the primary cell type present in the product. Epithelial cells are the primary cell type present in the product. Melanocytes are the primary cell type present in the product. Fibroblasts are the primary cell type present in the product. Urothelial cells are the primary cell type present in the product. Mesenchymal stromal cells are the primary cell type present in the product. Multiple cell types are present in the product. Source of Cells Group Adipose Tissue Umbilical Cord Cord Blood Bone Marrow The source of cells is not specified in the coding. Adipose tissue is the source of the primary cells in the product. Umbilical cord is the source of the primary cells in the product. Cord blood is the source of the primary cells in the product. Bone marrow is the source of the primary cells in the product. Origin of Scaffold Group Autologous Allogeneic Xeno Synthetic Scaffold type is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. The scaffold is formed from decellularized tissue from the intended recipient. The scaffold is formed from decellularized human tissue not from the intended recipient. The scaffold is formed from decellularized non-human animal tissue. The scaffold has been formed by chemical synthesis and does not contain human or animal materials.

7 Internationally Standardized inology for Regenerated Tissue 7 Scaffold Degradability Group Default: Not applicable/not specified Degradable Not degradable Not applicable because the regenerated tissue product does not contain a scaffold, or information about the composition of the scaffold is not encoded. Scaffold intended to be degraded or metabolized. Scaffold intended to remain as a permanent or semi-permanent structure. Storage Temperature Group RT Refg Cryopreserved The storage temperature is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Room temperature The product is to be stored at room temperature. Specific ranges may be specified by national authorities. Refrigerated The product is to be stored at refrigerated temperatures. Specific ranges may be specified by national authorities. Cryopreserved The product contains cryoprotectant(s) and is to be stored in the frozen or vitrified state. Further details may be stated in text on the label or in the accompanying documentation. Delivery Method Group Sheet The method of delivering the implanted cells is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. The product is presented as a sheet. Ancillary Substances Group Ancillary substances: Yes The presence of ancillary substances is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Ancillary substances are present in the product. Further details may be stated in text on the label or in the accompanying documentation.

8 Internationally Standardized inology for Regenerated Tissue 8 Excipients Group Excipients: Yes Excipients: Yes, including animal origin The presence of excipients is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Excipients are present in the product. Further details may be stated in text on the label or in the accompanying documentation. Excipients, including excipients of animal origin, are present in the product. Further details may be stated in text on the label or in the accompanying documentation.

9 Internationally Standardized inology for Regenerated Tissue 9 Figure 2 Illustration of the classes and attribute groups utilized for coding Regenerated Tissue. For each product, only one class and one attribute variable per attribute group can be selected. When the attribute is selected, it does not need to be included in the product description. In this example, the entire product description is REGENERATED EPIDERMIS Keratinocytes Sheet Ancillary substances: Yes.

10 Internationally Standardized inology for Regenerated Tissue 10 Regenerative Medicine Technical Advisory Group Participants Ineke Slaper-Cortenbach [Current Chair] Ruth Warwick [Former Chair] Francisca Agbanyo Julie Allickson John Armitage Jacques Galipeau Martin Hildebrandt Alyce Jones Mickey Koh Marina Maréchal Leigh Sims Poston Zbigniew Szczepiorkowski Izabela Uhrynowska-Tyszkiewicz Diane Wilson Paul Ashford Mónica Freire

ISBT 128 For Cellular Therapy

ISBT 128 For Cellular Therapy ISBT 128 For Cellular Therapy An Introduction 10 th Edition 2017 IN-005 ISBT 128 for Cellular Therapy, An Introduction 10 th Edition 2 Editor Paul Ashford, MSc. CEng. CSci. Executive Director ICCBBA Standards

More information

Coding and Labeling of Medical Devices Using ISBT 128

Coding and Labeling of Medical Devices Using ISBT 128 ISBT 128 STANDARD Coding and Labeling of Medical Devices Using ISBT 128 Version 1.7.0 June 2017 Tracking Number ICCBBA ST-011 ISBN-13: 978-1-933243-72-6 ISBN-10: 1-933243-72-4 Published by: ICCBBA PO Box

More information

Paul Ashford Executive Director ICCBBA

Paul Ashford Executive Director ICCBBA Introduction to ISBT 128 Paul Ashford Executive Director ICCBBA ICCBBA ICCBBA enhances safety for patients by managing the ISBT 128 international information standard for use in transfusion and transplantation.

More information

Overview of USP Efforts to Identify Naming Schemes for Tissues and Tissue-Based Products

Overview of USP Efforts to Identify Naming Schemes for Tissues and Tissue-Based Products Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World Overview of USP Efforts to Identify Naming Schemes for Tissues and Tissue-Based Products Darin Weber, Ph.D., Vice-Chair

More information

#SIS25th. 25th Annual Meeting Slides

#SIS25th. 25th Annual Meeting Slides 25th Annual Meeting Slides Stem Cell for Spine Care - From dish to disc Wenchun Qu, MD, PhD Mayo Clinic Rochester Disclosures ØConsultant, DePuy Synthes ØBoard of Directors, American Academy of Regenerative

More information

Cellular Therapy Products & NDC vs. ISBT128 Coding/Labeling

Cellular Therapy Products & NDC vs. ISBT128 Coding/Labeling Cellular Therapy Products & NDC vs. ISBT128 Coding/Labeling William E. Janssen, Ph.D. Director, Cell Therapies Facility Moffitt Cancer Center Tampa, Florida What is ISBT 128? Information standard for blood,

More information

PRIME-XV Cell Therapy Products by

PRIME-XV Cell Therapy Products by PRIME-XV Cell Therapy Products by Product List 2017 TRINOVA BIOCHEM now distributes the PRIME-XV Cell Therapy line by Irvine Scientific in Germany, Austria and Switzerland. Irvine Scientific is a worldwide

More information

Des cellules-souches dans le poumon : pourquoi faire?

Des cellules-souches dans le poumon : pourquoi faire? Des cellules-souches dans le poumon : pourquoi faire? Karl-Heinz Krause Dept. of Pathology and Immunology, Medical Faculty Dept. of Genetic and Laboratory Medicine, University Hospitals Geneva, Switzerland

More information

Regulatory Updates on Cellular Therapy Products in Japan

Regulatory Updates on Cellular Therapy Products in Japan Regulatory Updates on Cellular Therapy Products in Japan Daiju Okuda, Ph.D. Principle Reviewer Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA), Japan September

More information

Global Registration Identifier for Donors (GRID) Overview

Global Registration Identifier for Donors (GRID) Overview Global Registration Identifier for Donors (GRID) Overview Martin Maiers Director, Bioinformatics Research National Marrow Donor Program/Be The Match CIBMTR On behalf of thewmda GRID Task Force GRID Overview

More information

ISBT 128 coding system and the Single European Code: Introduction. Presented by: Jessy Lardon

ISBT 128 coding system and the Single European Code: Introduction. Presented by: Jessy Lardon ISBT 128 coding system and the Single European Code: Introduction Presented by: Jessy Lardon Single European Code (= SEC) The SEC is the unique identifier applied to tissues and cells distributed in the

More information

ISBT 128 STANDARD. Standard Terminology for Medical Products of Human Origin. Version 7.10 January 2018 Tracking Number ICCBBA ST-002

ISBT 128 STANDARD. Standard Terminology for Medical Products of Human Origin. Version 7.10 January 2018 Tracking Number ICCBBA ST-002 STANDARD Standard Terminology for Medical Products of Human Origin For Use with Product Description Code Database Version 7.10 January 2018 Tracking Number ICCBBA ST-002 Published by: ICCBBA PO Box 11309,

More information

Regulating Cell Therapy: An Ex-Regulators Perspective

Regulating Cell Therapy: An Ex-Regulators Perspective Regulating Cell Therapy: An Ex-Regulators Perspective Christopher A Bravery 1 Introduction Regulation of Healthcare products in the EU What is cell therapy? How does it fit into existing framework? Is

More information

NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY:

NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY: NEXT GENERATION ECM-BASED ALLOGRAFT TECHNOLOGY: Potent biological scaffolds strategically control stem cell fate and function, allowing our allografts to harness the regenerative potential of patient s

More information

What Are Stem Cells? Where Are These Stem Cells?

What Are Stem Cells? Where Are These Stem Cells? While stem cell therapies may seem to have appeared overnight, they have been practiced for some time prior to the recent burst in new applications and stem cell sources. The most recent developments in

More information

2015-Tissue Storage. Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey.

2015-Tissue Storage. Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey. 2015-Tissue Storage Form Approved OMB No. 0990-0457 Exp. Date 06/30/2020 Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey.

More information

Stephen Strom (Cell Transplantation and Regenerative Medicine, KI) Stem Cell Therapy of Liver Disease

Stephen Strom (Cell Transplantation and Regenerative Medicine, KI) Stem Cell Therapy of Liver Disease Final Programme Tuesday 13 th October Location: HERM Seminar Room, NOVUM, 4 th Floor (entrance through HERM) 9.15-9.20 Welcome and Introduction to the Sessions Chair: Hong Qian (HERM, KI) 9.20-10.15 Hong

More information

Agenzia Italiana del Farmaco

Agenzia Italiana del Farmaco Agenzia Italiana del Farmaco European Regulation on Advanced Therapies Cristina Pintus Head of European Relations Unit and Coordinator of the Advanced Therapy Project Italian Medicines Agency Proposal

More information

Guide to Clonetics and Poietics Cell Types

Guide to Clonetics and Poietics Cell Types Guide to Clonetics and Poietics Cell Types Clonetics and Poietics Cell Types - Sorted By Tissue Source Cryopreserved Human Cells Adipose Subcutaneous Preadipocytes PT-5001 PGM -2 PT-8002 Visceral Preadipocytes

More information

Single European Code for Tissues and Cells

Single European Code for Tissues and Cells Single European Code for Tissues and Cells Mr Richard Forde, Blood Tissues and Organs Inspector Health Products Regulatory Authority 17 th, HPRA Offices Overview: The Single European Code (SEC): Legislative

More information

Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020

Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020 Germany Tissue Engineered - Skin Substitutes Market Outlook to 2020 Reference Code: GDMECC0884DB Publication Date: October 2014 Page 1 1 Table of Contents 1 Table of Contents... 2 1.1 List of Tables...

More information

Challenges In Cell Product Labeling, Tracking And Traceability

Challenges In Cell Product Labeling, Tracking And Traceability Challenges In Cell Product Labeling, Tracking And Traceability April 4-5, 2008 Columbus, Ohio Dave Krugh, MT(ASCP)SBB, CLS,CLCP(NCA) Clinical Program Manager, BMT Program Clinical Instructor, Department

More information

Tissue Engineered Medical Products

Tissue Engineered Medical Products WORKSHOP 8 Tissue Organizer: Jeremy J. Rawlinson PhD Speakers: Jack E. Lemons, PhD Lawrence J. Bonassar, PhD Mauro R. Alini, PhD Michael J. Yaszemski, MD, PhD Standards for Tissue J. Lemons, University

More information

INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION

INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION Sixth Edition Version 6.1 NOTICE These Standards are designed to provide minimum guidelines

More information

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords Dr. Vasiliki E Kalodimou, Head of Flow Cytometry-Research and Regenerative Medicine Department, IASO-Maternity

More information

INTERNATIONAL STANDARDS FOR CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION FOR HEMATOPOIETIC CELLULAR THERAPIES

INTERNATIONAL STANDARDS FOR CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION FOR HEMATOPOIETIC CELLULAR THERAPIES INTERNATIONAL STANDARDS FOR CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION FOR HEMATOPOIETIC CELLULAR THERAPIES Draft Sixth Edition April 2014 NOTICE These Standards are designed to

More information

Future implications of regenerative medicine on assisted reproductive technology. Regenerative medicine. History of Regenerative medicine

Future implications of regenerative medicine on assisted reproductive technology. Regenerative medicine. History of Regenerative medicine Gyndolomiti: 2nd Congress on Gynaecology and Obstetrics February 1 6, 2015 St. Kassian / South Tyrol Regenerative medicine Future implications of regenerative medicine on assisted reproductive technology

More information

At the conclusion of this lesson you should be able to:

At the conclusion of this lesson you should be able to: Learning Objectives At the conclusion of this lesson you should be able to: Understand the key terms and definitions regarding stem cells Differentiate between the adult and embryonic stem cells Differentiate

More information

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 19.6.2002 COM(2002) 319 final 2002/0128(COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on setting standards of quality and

More information

Clinical Applications of Mesenchymal Stromal Cells

Clinical Applications of Mesenchymal Stromal Cells Clinical Applications of Mesenchymal Stromal Cells John Girdlestone PhD Stem Cells and Immunotherapies NHS Blood and Transplant, Oxford John Radcliffe Hospital Mesenchymal Stromal Cells (MSC) Fibroblastic,

More information

Special Report. medicine? Peter Marks, M.D., Ph.D., and Scott Gottlieb, M.D.

Special Report. medicine? Peter Marks, M.D., Ph.D., and Scott Gottlieb, M.D. The new england journal of medicine Special Report Balancing Safety and Innovation for Cell-Based Regenerative Medicine Peter Marks, M.D., Ph.D., and Scott Gottlieb, M.D. Regenerative medicine is a field

More information

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Fourth Edition

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Fourth Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration Fourth Edition INTERNATIONAL STANDARDS FOR CORD BLOOD COLLECTION, BANKING, AND RELEASE FOR ADMINISTRATION

More information

Stem Cells 101. Christopher Centeno, M.D. The Centeno-Schultz Clinic Colorado, USA

Stem Cells 101. Christopher Centeno, M.D. The Centeno-Schultz Clinic Colorado, USA Stem Cells 101 Christopher Centeno, M.D. The Centeno-Schultz Clinic Colorado, USA My background Began using stem cells to treat orthopedic conditions in 2005 Have published 16 peer reviewed publications

More information

Stem cells in regenerative medicine: introduction

Stem cells in regenerative medicine: introduction Published Online May 11, 2011 Stem cells in regenerative medicine: introduction Dusko Ilic 1, and Julia M. Polak 2* 1 Kings College London School of Medicine, Division of Women s Health, Assisted Conception

More information

HCT/P Regulation vs 361 Products

HCT/P Regulation vs 361 Products HCT/P Regulation - 351 vs 361 Products Presented by: Paul Gadiock February 15, 2017 Arent Fox LLP Washington, DC New York, NY Los Angeles, CA San Francisco, CA 1 Presentation Overview Introduction Public

More information

INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION

INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION Seventh Edition DRAFT May 2017 NOTICE These Standards are designed to provide minimum guidelines

More information

Inhibition of the prostaglandin-degrading enzyme 15-PGDH potentiates tissue regeneration. JournalClub Emilie Hrdliczka

Inhibition of the prostaglandin-degrading enzyme 15-PGDH potentiates tissue regeneration. JournalClub Emilie Hrdliczka Inhibition of the prostaglandin-degrading enzyme 15-PGDH potentiates tissue regeneration JournalClub 14.12.2015 Emilie Hrdliczka Facts Author: Yongyou Zhang Department of Medicine, Case Western Reserve

More information

The transfer of all HPC products should be transferred to and from the courier in a clinical setting.

The transfer of all HPC products should be transferred to and from the courier in a clinical setting. INTRODUCTION The WMDA is a worldwide network of organisations that provide haematopoietic progenitor cells (HPC) from voluntary unrelated donors to those in need of hematopoietic stem cell transplantation.

More information

Current approaches and future perspectives on strategies for the development of personalized

Current approaches and future perspectives on strategies for the development of personalized Expert Review of Precision Medicine and Drug Development Personalized medicine in drug development and clinical practice ISSN: (Print) 2380-8993 (Online) Journal homepage: http://www.tandfonline.com/loi/tepm20

More information

Exhibit Floorplan update Grand Ballroom ABCD

Exhibit Floorplan update Grand Ballroom ABCD Exhibit Floorplan update Grand Ballroom ABCD 100 102 104 106 Booth # Company/Organization 100 Lonza Walkersville, Inc. 101 Compass Biomedical 102 stemtrak 101 105 109 104 Biosafe America, Inc. 105 Waisman

More information

From Stem Cell to Any Cell

From Stem Cell to Any Cell sciencenewsforkids.org http://www.sciencenewsforkids.org/2005/10/from-stem-cell-to-any-cell-2/ From Stem Cell to Any Cell By Emily Sohn / October 11, 2005 For maybe a day, about 9 months before you were

More information

Bar coding in the Blood Bank

Bar coding in the Blood Bank Bar coding in the Blood Bank for Ease, Speed + Accuracy Ann Mountain Wilson, TSO MUHC ICCBBA-GS1 International Meeting June 20, 2008 Bar coding in the blood bank Bar coded Blood components Non bar coded

More information

Over the past decade, autologous and allogeneic grafts

Over the past decade, autologous and allogeneic grafts TISSUE ENGINEERING: Part B Volume 22, Number 3, 2016 ª Mary Ann Liebert, Inc. DOI: 10.1089/ten.teb.2015.0290 REVIEW ARTICLE Cell-Derived Extracellular Matrix: Basic Characteristics and Current Applications

More information

Introduction to Cell- Biomaterial Engineering!

Introduction to Cell- Biomaterial Engineering! Introduction to Cell- Biomaterial Engineering! Module 3, Lecture 1! 20.109 Spring 2010! Topics for Lecture 1!! Introduction to tissue engineerin! motivation"! basic principles + examples"! Introduction

More information

STANDARDS FOR IMMUNE EFFECTOR CELLS

STANDARDS FOR IMMUNE EFFECTOR CELLS STANDARDS FOR IMMUNE EFFECTOR CELLS January 2017 NOTICE These Standards are designed to provide minimum guidelines for programs, facilities, and individuals performing cellular therapy or providing support

More information

2016 North American Cell Therapeutics Technology Innovation Award

2016 North American Cell Therapeutics Technology Innovation Award 2016 North American Cell Therapeutics Technology Innovation Award 2016 Contents Background and Company Performance... 3 Industry Challenges... 3 Technology Attributes... 3 Conclusion... 8 Significance

More information

Chapter 8 Cell Diversity

Chapter 8 Cell Diversity Chapter 8 Cell Diversity Mr. C. Biology 1 Future? Chapter 8 Cell Diversity Cells, Tissues, Organs and Systems Cells have different shapes because they have different jobs to do. A nerve cell is very different

More information

Oroxcell Cellular Toxicity

Oroxcell Cellular Toxicity Oroxcell 2009 Cellular Toxicity Table of contents Cellular Toxicity 1. Episkin Episkin model by SkinEthic Skin corrosion Skin irritation 2. Reconstructed Human Epidermis (RHE) RHE model by SkinEthic Validation

More information

PART 1. DRAFT GUIDING PRINCIPLES ON HUMAN ORGAN TRANSPLANTATION

PART 1. DRAFT GUIDING PRINCIPLES ON HUMAN ORGAN TRANSPLANTATION FORTY-FOURTH WORLD HEALTH ASSEMBLY GENEVA, 6-16 MAY 1991 WHA44/1991/REC/1 ANNEXES ANNEX 6 HUMAN ORGAN TRANSPLANTATION 1 PART 1. DRAFT GUIDING PRINCIPLES ON HUMAN ORGAN TRANSPLANTATION Introduction 1.In

More information

Cell- and tissue-based therapies

Cell- and tissue-based therapies FOCUS ON... REGENERATIVE MEDICINE Author Insights Online Exclusive www.bioprocessintl.com/bpiextra Standards for Ancillary Materials Used in Cell- and Tissue-Based Therapies by Fouad Atouf, Nicole M. Provost,

More information

VIII. Validation Evaluation Comparative Chart Application Fields of PRP Advantages of MiroPRP for skin treatments MicroPRP and Mico-Mesotherapy

VIII. Validation Evaluation Comparative Chart Application Fields of PRP Advantages of MiroPRP for skin treatments MicroPRP and Mico-Mesotherapy The New Technology for Safe Platelet Activation INDEX I. Blood Composition II. What is PRP Therapy? III. Growth Factors Present in PRP IV. Why is PRP concentration significant? V. How are Platelets Activated?

More information

Life Sciences. Novel ECM Mimetic Surfaces for Cell Expansion and Differentiation

Life Sciences. Novel ECM Mimetic Surfaces for Cell Expansion and Differentiation Life Sciences Novel ECM Mimetic Surfaces for Cell Expansion and Differentiation ASCB December 17, 2012 Marshall Kosovsky, Ph.D., Technical Support Manager Topics for Discussion Introduction Overview of

More information

THE RIGENERA PROJECT

THE RIGENERA PROJECT THE RIGENERA PROJECT About Our Company HBW s.r.l. HUMAN BRAIN WAVE HBW was founded in April 2012 to provide innovative medical services by producing biotechnological devices for medical applications. HBW

More information

Fujifilm s Initiatives in Regenerative Medicine

Fujifilm s Initiatives in Regenerative Medicine Fujifilm s Initiatives in Regenerative Medicine Shigetaka Komori Chairman and CEO FUJIFILM Holdings Corporation March 30, 2015 Priority Business: Healthcare Expand business with focus on six core business

More information

Supplemental Information. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Leigh Turner and Paul Knoepfler

Supplemental Information. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Leigh Turner and Paul Knoepfler Cell Stem Cell, Volume 19 Supplemental Information Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry Leigh Turner and Paul Knoepfler Supplemental Information Search approach We used

More information

Wider Adoption of Regenerative Medicine Driven by Open Innovation

Wider Adoption of Regenerative Medicine Driven by Open Innovation Review Vol. 64 (2016), No. 10 693 Featured Articles Wider Adoption of Regenerative Medicine Driven by Open Innovation Kohin Shu, Ph.D., Engineering Masaharu Kiyama Takayuki Nozaki, Ph.D., Medical Science

More information

Review. Muse Cells Provide the Pluripotency of Mesenchymal Stem Cells: Direct Contribution of Muse Cells to Tissue Regeneration

Review. Muse Cells Provide the Pluripotency of Mesenchymal Stem Cells: Direct Contribution of Muse Cells to Tissue Regeneration Cell Transplantation, Vol. 25, pp. 849 861, 2016 0963-6897/16 $90.00 +.00 Printed in the USA. All rights reserved. DOI: http://dx.doi.org/10.3727/096368916x690881 Copyright Ó 2016 Cognizant, LLC. E-ISSN

More information

Insight to Gene Techno Science Co.,Ltd

Insight to Gene Techno Science Co.,Ltd Unlimited drug discovery from the beginning Ticker symbol: 4584 Insight to Gene Techno Science Co.,Ltd November 2017 2 Corporate Overview Chief Executive Founded March 2001 Masaharu Tani, President Listed

More information

Antibody-based HLA (Human Leucocyte Antigen ) tissue-typing technologies

Antibody-based HLA (Human Leucocyte Antigen ) tissue-typing technologies Human AB Serum Product Description Human AB Serum is a vital cell culture reagent for some human cell types providing growth factors, vitamins, nutrients as well as trace elements and transport factors,

More information

1. Materials Challenges in Regenerative Medicine

1. Materials Challenges in Regenerative Medicine 1. Materials Challenges in Regenerative Medicine Open Access Library Leszek Adam Dobrzański*, Eugeniusz Hajduczek and Andrzej Hudecki Silesian University of Technology, Mechanical Engineering Faculty,

More information

Key changes in new BCSH Transfusion I.T. Guidelines. Debbie Asher EPA Network Transfusion Manager Member, BCSH Guideline Writing Group

Key changes in new BCSH Transfusion I.T. Guidelines. Debbie Asher EPA Network Transfusion Manager Member, BCSH Guideline Writing Group Key changes in new BCSH Transfusion I.T. Guidelines Debbie Asher EPA Network Transfusion Manager Member, BCSH Guideline Writing Group Membership Joan Jones Head of Quality, Welsh Blood Service Paul Ashford

More information

Embryonic Stem Cell Research Oversight Committee (ESCRO) Application Form

Embryonic Stem Cell Research Oversight Committee (ESCRO) Application Form Embryonic Stem Cell Research Oversight Committee (ESCRO) Application Form A. Demographic Information Date of Submission: Reason for Submission: New Project Response to Comments Reconsideration Disapproval

More information

Stem Cell Biology and Regenerative Medicine

Stem Cell Biology and Regenerative Medicine Stem Cell Biology and Regenerative Medicine Series Editor Kursad Turksen, Ph.D. kturksen@ohri.ca For further volumes: http://www.springer.com/series/7896 wwwwwwwwwww David S. Allan Editors Dirk Strunk

More information

Genetic Engineering 1

Genetic Engineering 1 Genetic Engineering 1 1952 First animal cloned Northern Leapord Frog Robert Briggs and Thomas King 2 1996 Dolly The first sheep to be cloned from ADULT cells is born. 3 4 5 The possibility that through

More information

Regenerative Medicine for Joint Disease. Regenerative Medicine for Joint Disease. Regenerative Medicine for Joint Disease

Regenerative Medicine for Joint Disease. Regenerative Medicine for Joint Disease. Regenerative Medicine for Joint Disease Regenerative Medicine for Joint Disease Ok, may be more correctly considered disease modulation and not regeneration! Your Tour Guide - Steve Budsberg Regenerative Medicine for Joint Disease Regenerative

More information

European Regenerative Medicine Firms & Their Strategic Approaches. Michael Morrison University of York

European Regenerative Medicine Firms & Their Strategic Approaches. Michael Morrison University of York European Regenerative Medicine Firms & Their Strategic Approaches Michael Morrison University of York OVERVIEW Creating the European RM Universe of firms Characterizing the European RM Universe Strategic

More information

Facts and theories of organ regeneration in adults

Facts and theories of organ regeneration in adults Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructor: I. V. Yannas Facts and theories of organ regeneration in adults I.V.Yannas, PhD

More information

Recent Progress in ips Cell Research and Application

Recent Progress in ips Cell Research and Application Recent Progress in ips Cell Research and Application Shinya Yamanaka, M.D., Ph.D. Center for ips Cell Research and Application (CiRA), Kyoto University, Japan Takeda - CiRA Joint Program, Shonan, Japan

More information

BD MOSAIC h MSC CELL CULTURE ENVIRONMENT DEFINED SERUM FREE

BD MOSAIC h MSC CELL CULTURE ENVIRONMENT DEFINED SERUM FREE BD MOSAIC h MSC CELL CULTURE ENVIRONMENT DEFINED SERUM FREE As the promise of stem cell therapy grows, so does the need for reliable tools for cell expansion in both research and clinical applications.

More information

Copyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.

Copyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited. Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics

More information

Human Embryonic Stem Cell Research vs. Alternative Stem Cell Research: Is there a compromise?

Human Embryonic Stem Cell Research vs. Alternative Stem Cell Research: Is there a compromise? John Carroll University Carroll Collected Senior Honors Projects Theses, Essays, and Senior Honors Projects Spring 2016 Human Embryonic Stem Cell Research vs. Alternative Stem Cell Research: Is there a

More information

The Role of Standards in U.S. FDA Regulation of Cellular Therapy Products

The Role of Standards in U.S. FDA Regulation of Cellular Therapy Products The Role of Standards in U.S. FDA Regulation of Cellular Therapy Products Judith Arcidiacono M.S. International Regulatory Expert Standards Development Activities Liaison U.S. Food and Drug Administration

More information

Hematopoietic Cell Transplant (HCT) Infusion Form

Hematopoietic Cell Transplant (HCT) Infusion Form Instructions for Hematopoietic Stem Cell Transplant (HCT) Infusion (Form 2006 Revision 4) This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Hematopoietic

More information

Regeneration of spinal cord injury (SCI) : What we know so far. By: Kendra Michaud

Regeneration of spinal cord injury (SCI) : What we know so far. By: Kendra Michaud Regeneration of spinal cord injury (SCI) : What we know so far By: Kendra Michaud INTRODUCTION BACKGROUND/IMPACT Neerumalla, Dr. Ravali. Spinal Cord Injury - Causes, Symptoms, Diagnosis, Treatment & Prevention.

More information

Medicyte GmbH. Infinity Gets Cultured. European Business Development Conference, Dresden October 2014 Björn F. Lindemann, CEO

Medicyte GmbH. Infinity Gets Cultured. European Business Development Conference, Dresden October 2014 Björn F. Lindemann, CEO Medicyte GmbH Infinity Gets Cultured European Business Development Conference, Dresden October 2014 Björn F. Lindemann, CEO Medicyte GmbH Founded 2007, privately owned Unique IP protected technology ISO

More information

Bioreactors in tissue engineering

Bioreactors in tissue engineering Bioreactors in tissue engineering S. Swaminathan Director Centre for Nanotechnology & Advanced Biomaterials School of Chemical & Biotechnology SASTRA University Thanjavur 613 401 Tamil Nadu Joint Initiative

More information

FACT - CIBMTR Data Audit Collaboration

FACT - CIBMTR Data Audit Collaboration FACT - CIBMTR Data Audit Collaboration Phyllis I. Warkentin, MD FACT Chief Medical Officer February 2017 FACT-CIBMTR Data Audit Collaboration History of data audits The joint FACT-CIBMTR Task Force becomes

More information

Stem Cells. Part 1: What is a Stem Cell? STO Stem cells are unspecialized. What does this mean?

Stem Cells. Part 1: What is a Stem Cell? STO Stem cells are unspecialized. What does this mean? STO-120 Stem Cells Part 1: What is a Stem Cell? Stem cells differ from other kinds of cells in the body. When a stem cell divides by mitosis, each new cell has the potential to either remain a stem cell

More information

3D Cell Culture Product Intro. Bio-Byblos Biomedical

3D Cell Culture Product Intro. Bio-Byblos Biomedical 3D Cell Culture Product Intro Bio-Byblos Biomedical Rundown Product Intro Cellusponge Series Go Matrix Applications Upcoming Products Degradable series Cellusponge CB series Cell Alignment plate Vivoalign

More information

Blue Marble University Biology Course Handbook

Blue Marble University Biology Course Handbook Blue Marble University Biology Course Handbook A Summary of Course Descriptions Courses and Content Subject to Change Without Notice BlueMarbleUniversity.com Info@bluemarbleuniversity.com Stem Cell Biology

More information

ABPI response to European Commission consultation on advanced therapy medicinal products

ABPI response to European Commission consultation on advanced therapy medicinal products ABPI response to European Commission consultation on advanced therapy medicinal products 28 March 2013 ABPI response to European Commission consultation on the regulation of advanced therapy medicinal

More information

Stem Cell Principle -

Stem Cell Principle - Effective Date: 31.10.2017 Doc ID: 20290214 Version: 1.0 Status: Approved Planned Effective Date: 31-Oct-2017 00:00 CET (Server Date) Stem Cell Principle - Rationale Research on human stem cells and their

More information

Updates on global movement in regulation of Advanced Therapeutics

Updates on global movement in regulation of Advanced Therapeutics DISCLAIMER : The contents of this presentation represent the view of this presenter only, and do not represent the views and/or policies of the PMDA Updates on global movement in regulation of Advanced

More information

Stem Cells: A Primer National Institutes of Health

Stem Cells: A Primer National Institutes of Health Stem Cells: A Primer National Institutes of Health I. INTRODUCTION Research on stem cells is advancing knowledge about how an organism develops from a single cell and how healthy cells replace damaged

More information

Tissue Engineered Products need and requirements for an appropriate harmonised EU regulatory framework

Tissue Engineered Products need and requirements for an appropriate harmonised EU regulatory framework Tissue Engineered Products need and requirements for an appropriate harmonised EU regulatory framework Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen

More information

Measurement of Hematopoietic Stem Cell Potency Prior to Transplantation

Measurement of Hematopoietic Stem Cell Potency Prior to Transplantation WHITE PAPER Measurement of Hematopoietic Stem Cell Potency Prior to Transplantation February, 2009 This White Paper is a forward-looking statement. It represents the present state of the art and future

More information

Xeno-Free Systems for hesc & hipsc. Facilitating the shift from Stem Cell Research to Clinical Applications

Xeno-Free Systems for hesc & hipsc. Facilitating the shift from Stem Cell Research to Clinical Applications Xeno-Free Systems for hesc & hipsc Facilitating the shift from Stem Cell Research to Clinical Applications NutriStem Defined, xeno-free (XF), serum-free media (SFM) specially formulated for growth and

More information

CNA BIOTECH Co., Ltd.

CNA BIOTECH Co., Ltd. CNA BIOTECH Co., Ltd. www.cnabiotech.com C o n t e n t 3_ 4_ 6_ 7_ 8_ 9_ 10_ 11_ CNA BIOTECH CO.Ltd 2 3 History 2002. 12. : CNABIOTECH Founded. Business Incubator in ChungBuk Provincial University of Science

More information

Within minutes following injury to the

Within minutes following injury to the The potential role of stem cells in wound healing KEY WORDS Bone-marrow derived Mesenchymal Scaffold Stem cell Wound healing consists of an intricate and highly coordinated process during which the skin

More information

REGENERATIVE MEDICINE

REGENERATIVE MEDICINE a School of Biomedical Sciences, Queensland University of Technology, Brisbane, Australia; b Institute of Health & Biomedical Innovation, Queensland University of Technology; c Queensland Eye Institute,

More information

Stem cells and motor neurone disease

Stem cells and motor neurone disease Stem cells and motor neurone disease F Stem cell research has fuelled hope of a treatment for a variety of conditions. This information sheet explains what these cells are and includes details of the current

More information