Nuts and Bolts of Planning MSC Clinical Trials

Size: px
Start display at page:

Download "Nuts and Bolts of Planning MSC Clinical Trials"

Transcription

1 Nuts and Bolts of Planning MSC Clinical Trials Lawrence Couture, City of Hope Robert Deans, Athersys Robert Preti, Progenitor Cell Therapy EJ Read, Blood Systems Research Institute

2 Workshop Discussion Points A heavy emphasis has been placed on translation research initiatives by state governments and federal agencies Many investigators with basic research findings are looking for a path from bench to bedside Institutions vary in terms of guidance translational research, and networks to assist in therapeutic cell production, Regulatory communication, financial support for Phase I proof of concept studies.

3 MSC Translational Progress Clinical Proof of Concept First 10 Years Lazarus [Bone Marrow Transplant (1995) 16:557] Horwitz [Nature Medicine (1999) 5:309] Osiris Phase I autologous, allogeneic MSC in transplant setting Efficacy Trials Second 10 Years Placebo controlled studies Branching Regulatory strategies broad translational exploration Alternate models for practicing therapy clinical consortia and industry Broad Translational Exploration Underway Deans ISCT 2009

4 Osiris Development Path: Immunomodulation HSC transplant Ph I, II 46 patients Doses: 1, 2.5, 5 mpk GI GvHD / Crohn s [Planned, not executed GI GvHD Ph I II] Crohns Ph II 10 patients Doses: 2, 8 mpk 4 sites Biologic refractory Crohns Ph III 258 patients Doses: 600MM 4inf 2wks 50 sites Steroid refractory GvHD Pediatric compassionate use 6 patients Ph II Ph III 14 patients 240 patients 8 mpk/inf every3d max8 2inf/wk 4wks 80 sites Acute GvHD Ph II 32 patients 16 sites Dosing: 2, 8 mpk; 2 infusions, 3d apart Ph III 184 patients Dosing: 2 mpk/inf; 6 infusions 50 sites Type I Diabetes COPD AMI Early onset T1 Ph II 60 patients 3 infusion / 60 days Ph II 60 patients Deans ISCT 2009

5 Dominici, M., et al (2006) Minimal criteria for defining multipotent mesenchymal stromal cells Cytotherapy 8: Lot Release Expectations Sterility Viability, Identity, Purity CD105, CD73 positive CD45, class II HLA negative Potency Differentiation into multiple mesenchymal lineages (bone, fat, cartilage) Karyotype normal stable karyotype N = 3 or greater to qualify process Product can be released to patient while final sterility testing is completed, provided appropriate corrective actions are in place

6 Discussion Points

7 Clinical Manufacturing Discussion Advantages and differences between cell manufacturing and contract services Private sector Academic cell processing centers Vector production and integration into clinical manufacturing How to bring partners together Process transfer and qualification requirements What works and what doesn t Accessing experience Master file referencing Who owns the IND?

8 Regulatory Discussion What s in an IND package? How can one receive FDA feedback in advance of IND filing? What are patient data and safety monitoring requirements, and what support infrastructure can be accessed? What additional considerations are required for gene therapy protocols? What are the patient data and safety monitoring requirements, and what support infracstructure can be accessed? How can multicenter trials be managed in the context of multiple cell processing production centers?

9 Trial Design and Logistics How should pre clinical efficacy and safety study requirements integrate with clinical dosing and administration What institutional review committees are required? IRB, Scientific Committees, RAC How is patient safety and data oversight managed at your institution? How do stem cell processing centers integrate with other departments for cell dosing and infusion?

10 What are the costs and how can they be managed? Cost centers Manufacturing Patient treatment, monitoring Patient follow up costs outside of standard of care Physician oversight Indemnity Where can funding be obtained for clinical studies? EU Framework Programs NIH, NHLBI PACT CIRM Foundations industry

11

Stem Cell Therapy. THE DARK AND BRIGHT ASPECTS of Stem Cell Therapy

Stem Cell Therapy. THE DARK AND BRIGHT ASPECTS of Stem Cell Therapy Stem Cell Therapy THE DARK AND BRIGHT ASPECTS of Stem Cell Therapy Stem Cells Our last Weapon? The last weapon in the medical armamentarium? Bye the way.. What IS a last weapon? I don t know about today,

More information

Cord Blood for Cellular Therapy: A Snapshot of this Evolving Market Landscape

Cord Blood for Cellular Therapy: A Snapshot of this Evolving Market Landscape GENReports: Market & Tech Analysis Cord Blood for Cellular Therapy: A Snapshot of this Evolving Market Landscape > Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US enal@selectbio.us

More information

RITMIR024 - STEM CELL RESEARCH IN CARDIOLOGY

RITMIR024 - STEM CELL RESEARCH IN CARDIOLOGY 1. SCOPE AND METHODOLOGY 2. REPORT SYNOPSIS 2.1 General Definitions Myoblasts Pluripotent Cells Multipotent Cells Progenitor Cells Role of Stem Cells in Repairing the Heart Stem Cell Therapy Stem Cells

More information

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC ISCT Conference, New Zealand, April 2013 April 1 st 2013 NIBSC will become part of the Medicines and

More information

The Cell Therapy Catapult

The Cell Therapy Catapult The Cell Therapy Catapult Keith Thompson CEO January 29 2013 info@ct.catapult.org.uk Catapult is a Technology Strategy Board programme The Launch of Catapults Hauser 2 Hauser Report Creating new manufacturing

More information

Stem Cells and Inner Ear Cell Regeneration. Stefan Heller Stanford University School of Medicine

Stem Cells and Inner Ear Cell Regeneration. Stefan Heller Stanford University School of Medicine Stem Cells and Inner Ear Cell Regeneration Stefan Heller Stanford University School of Medicine Embryonic stem cells Induced pluripotent stem cells Somatic stem cells 50 µm Derived from the inner cell

More information

Stem Cell-based Therapies and FDA Regulations

Stem Cell-based Therapies and FDA Regulations Stem Cell-based Therapies and FDA Regulations By Trina Slabiak, MS, RAC Stem cell-based therapies are arriving in the clinic as Phase 1 studies. Which technological challenges and US Food and Drug Administration

More information

CORD BLOOD TRANSPLANTATION STUDY EXPANDED ACCESS PROTOCOL APPENDIX A SAMPLE CONSENT FORM

CORD BLOOD TRANSPLANTATION STUDY EXPANDED ACCESS PROTOCOL APPENDIX A SAMPLE CONSENT FORM APPENDIX A SAMPLE CONSENT FORM CORD BLOOD TRANSPLANTATION (COBLT) STUDY SAMPLE CONSENT FORM FOR THE EXPANDED ACCESS PROTOCOL You (your child) are being asked to take part in a clinical research study.

More information

Corporate Medical Policy Cord Blood as a Source of Stem Cells

Corporate Medical Policy Cord Blood as a Source of Stem Cells Corporate Medical Policy Cord Blood as a Source of Stem Cells File Name: Origination: Last CAP Review: Next CAP Review: Last Review cord_blood_as_a_source_of_stem_cells 2/2001 3/2015 3/2016 3/2015 Description

More information

Corporate Medical Policy Cord Blood as a Source of Stem Cells

Corporate Medical Policy Cord Blood as a Source of Stem Cells Corporate Medical Policy Cord Blood as a Source of Stem Cells File Name: Origination: Last CAP Review: Next CAP Review: Last Review cord_blood_as_a_source_of_stem_cells 2/2001 3/2015 3/2016 3/2015 Description

More information

Statement of Joanne Kurtzberg, M.D.

Statement of Joanne Kurtzberg, M.D. Statement of Joanne Kurtzberg, M.D. President of the Cord Blood Association Jerome Harris Distinguished Professor of Pediatrics and Pathology Chief Scientific Officer and Medical Director, Robertson Clinical

More information

Stem Cells Market Trends based on Primary Industry Analysis

Stem Cells Market Trends based on Primary Industry Analysis GENReports: Market & Tech Analysis Stem Cells Market Trends based on Primary Industry Analysis > Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US enal@selectbio.us > Gary Oosta,

More information

STEM CELL FELLOWSHIP

STEM CELL FELLOWSHIP Module I: The Basic Principles of Stem Cells 1. Basics of Stem Cells a. Understanding the development of embryonic stem cells i. Embryonic stem cells ii. Embryonic germ cells iii. Differentiated stem cell

More information

A Closer Look at Stem Cell Treatments An ISSCR Initiative

A Closer Look at Stem Cell Treatments An ISSCR Initiative A Closer Look at Stem Cell Treatments An ISSCR Initiative Heather Rooke IASCR, Washington, DC USA, October 19-20, 2010 Commercialized Stem Cell Treatments on the Web Exploitation of the much-cited promise

More information

IWK September 22, 2010. Cord Blood Program

IWK September 22, 2010. Cord Blood Program IWK September 22, 2010 Cord Blood Program Discussion Topics Insception s core values and core purpose Insception s experience Umbilical Cord Blood Stem cell Uses Insception Services in a Hospital Partnership

More information

The Power & Potential of Cord Blood

The Power & Potential of Cord Blood The Power & Potential of Cord Blood Donna Regan, MT(ASCP)SBB, Director St. Louis Cord Blood Bank & Cellular Therapy Laboratory SSM Cardinal Glennon Children s Medical Center April 30, 2014 Objectives Since

More information

Stem cells and cellular therapies: from research to clinic. ns,, PhD Faculty of Biology University of Latvia

Stem cells and cellular therapies: from research to clinic. ns,, PhD Faculty of Biology University of Latvia Stem cells and cellular therapies: from research to clinic Janis Ancans ns,, PhD Faculty of Biology University of Latvia Our cells Human body originates from one stem cell Conventional drugs Long history

More information

4. All cord blood banks should be subject to the same standards, regulations and accreditation requirements.

4. All cord blood banks should be subject to the same standards, regulations and accreditation requirements. WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage The WMDA Board adopted this policy on 25 th of May 2006. Policy updated _April 2011 The Cord Blood Working Group and

More information

STEM CELLS FROM THE UMBLICAL CORD BLOOD AND UMBLICAL CORD TISSUE

STEM CELLS FROM THE UMBLICAL CORD BLOOD AND UMBLICAL CORD TISSUE STEM CELLS FROM THE UMBLICAL CORD BLOOD AND UMBLICAL CORD TISSUE What are Stem Cells? Stem cells are the basic building blocks of all the cells, tissues and organs in the human body. The role of the stem

More information

Hematopoiesis i starts from. HPC differentiates t to sequentially more mature. HPC circulate in very low

Hematopoiesis i starts from. HPC differentiates t to sequentially more mature. HPC circulate in very low Upstate Cord Blood Bank Hematopoietic Progenitor Cells Hematopoiesis i starts from self renewing HPC HPC differentiates t to sequentially more mature blood cells HPC circulate in very low numbers in adults

More information

Cord derived MSC-Like Placenta derived Membranes- Matrix- Cells- MSC-like,

Cord derived MSC-Like Placenta derived Membranes- Matrix- Cells- MSC-like, Bank Public/Pvt Bank other cells Ship and distribute Collect and process other samples Support development of novel uses One cord Blood Unit Non stem cells RBC s Plateletes T B Monocytes NK cells Stem

More information

STEM CELL THERAPEUTIC OUTCOMES DATABASE

STEM CELL THERAPEUTIC OUTCOMES DATABASE C W Bill Young Cell Transplantation Program STEM CELL THERAPEUTIC OUTCOMES DATABASE BUS06_1ppt Stem Cell Therapeutic and Research Act of 2005 (PL 109-129) 129) Authorizing law, preceded by efforts to:

More information

Autologous Cellular Therapies. Adrian Gee Center for Cell & Gene Therapy Baylor College of Medicine Production Assistance for Cellular Therapy (PACT)

Autologous Cellular Therapies. Adrian Gee Center for Cell & Gene Therapy Baylor College of Medicine Production Assistance for Cellular Therapy (PACT) Autologous Cellular Therapies Adrian Gee Center for Cell & Gene Therapy Baylor College of Medicine Production Assistance for Cellular Therapy (PACT) Autologous Cellular Therapies Definition Advantages

More information

TERUMO Corporation Business Strategy Conference

TERUMO Corporation Business Strategy Conference TERUMO Corporation Business Strategy Conference THERAPEUTIC SYSTEMS & CELL PROCESSING MARK FLOWER GLOBAL MARKETING December 5, 2011 Regenerative Medicine, Cell Therapy, & Cell Processing Regenerative Medicine

More information

US Regulations for Import and Export of Cell Therapy Products

US Regulations for Import and Export of Cell Therapy Products US Regulations for Import and Export of Cell Therapy Products Kurt Gunter, MD U Minnesota UCB Transplants (2001-2007)* Total units: 790 Number US banks: 19 Number non-us banks: 12 % units from non-us banks:

More information

Processing & Utilization of Cord Blood for Transplant

Processing & Utilization of Cord Blood for Transplant Processing & Utilization of Cord Blood for Transplant 2010-Jan Jan-15 Nicole L. Prokopishyn, PhD HPC Processing Laboratory Director Calgary Laboratory Services Overview Cord Blood Processing Pre-Freeze

More information

Improving Quality in Cellular Therapy with FACT Accreditation. The Foundation for the Accreditation of Cellular Therapy

Improving Quality in Cellular Therapy with FACT Accreditation. The Foundation for the Accreditation of Cellular Therapy Improving Quality in Cellular Therapy with FACT Accreditation The Foundation for the Accreditation of Cellular Therapy 1 Goals and Services of FACT Promote quality patient care and laboratory practice

More information

5. All cord blood banks should be subject to the same standards, regulations and accreditation requirements.

5. All cord blood banks should be subject to the same standards, regulations and accreditation requirements. WMDA Policy Statement for the Utility of Autologous or Family Cord Blood Unit Storage (This policy statement has been approved and adopted by the WMDA board on the 25 th of May 2006) The Cord Blood Registries

More information

The Power & Potential of Cord Blood

The Power & Potential of Cord Blood The Power & Potential of Cord Blood Donna Regan, MT(ASCP)SBB, Director St. Louis Cord Blood Bank & Cellular Therapy Laboratory SSM Cardinal Glennon Children s Medical Center September 18, 2013 Objectives

More information

Challenges in the Regulation of Pediatric Clinical Trials

Challenges in the Regulation of Pediatric Clinical Trials Challenges in the Regulation of Pediatric Clinical Trials Wilson W. Bryan, M.D. FDA / CBER / OCTGT wilson.bryan@fda.hhs.gov National Institutes of Health Recombinant DNA Advisory Committee (RAC) Meeting

More information

Extemporaneously Prepared Early Phase Clinical Trial Materials

Extemporaneously Prepared Early Phase Clinical Trial Materials Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development

More information

Guidance for Industry and FDA Staff

Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution

More information

Cord Blood: Thawing & Infusion Practical Methods

Cord Blood: Thawing & Infusion Practical Methods Cord Blood: Thawing & Infusion Practical Methods Donna M Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Objectives Present variety of product configurations

More information

Umbilical Cord Blood Stem Cells Current Status & Future Potential

Umbilical Cord Blood Stem Cells Current Status & Future Potential Umbilical Cord Blood Stem Cells Current Status & Future Potential Natasha Ali Assistant Professor Haematology Department of Pathology & Laboratory Medicine/Oncology The Aga Khan University Email: natasha.ali@aku.edu

More information

Summary of Advisory Council on Blood Stem Cell Transplantation: Recommendations and Status

Summary of Advisory Council on Blood Stem Cell Transplantation: Recommendations and Status of Advisory Council on Blood Stem Cell Transplantation: Recommendations and Shelley Grant Branch Chief, Blood Stem Cell Transplantation Program September 11, 2015 Overview December 20, 2005 - HRSA began

More information

Cord Blood Market Trends, circa 2014

Cord Blood Market Trends, circa 2014 GENReports: Market & Tech Analysis Cord Blood Market Trends, circa 2014 > Enal Razvi, Ph.D. Managing Director Select Biosciences, Inc. enal@selectbio.us Topic Introduction and Scope The focus of this GEN

More information

Human Umbilical Cord-derived Multipotent Mesenchymal Stromal Cells (huc-msc) Handling Instructions

Human Umbilical Cord-derived Multipotent Mesenchymal Stromal Cells (huc-msc) Handling Instructions Human Umbilical Cord-derived Multipotent Mesenchymal Stromal Cells (huc-msc) Order No.: 19401-005, 19401-010 Handling Instructions For preclinical ex vivo use. Not intended for therapeutic use. Table of

More information

Stem Cell Quick Guide: Stem Cell Basics

Stem Cell Quick Guide: Stem Cell Basics Stem Cell Quick Guide: Stem Cell Basics What is a Stem Cell? Stem cells are the starting point from which the rest of the body grows. The adult human body is made up of hundreds of millions of different

More information

UMBILICAL CORD BLOOD HARVESTING & STORAGE

UMBILICAL CORD BLOOD HARVESTING & STORAGE Protocol: TRP009 Effective Date: October 14, 2013 UMBILICAL CORD BLOOD HARVESTING & STORAGE Table of Contents Page COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE... 1 BACKGROUND... 2 CLINICAL EVIDENCE...

More information

Cord Blood Banking and Biologic License Application (BLA) November 19, 2010

Cord Blood Banking and Biologic License Application (BLA) November 19, 2010 Cord Blood Banking and Biologic License Application (BLA) November 19, 2010 1 Webinar Presenters Tara Sadeghi, BS University of Texas MD Anderson Cord Blood Bank Michele Carbone, MS, CLS, MT(ASCP)SH,DLM,CQM,

More information

Stem Cell Banking & Application: Guidelines & Regulatory Framework

Stem Cell Banking & Application: Guidelines & Regulatory Framework Stem Cell Banking & Application: Guidelines & Regulatory Framework Dr. Geeta Jotwani Assistant Director General Indian Council of Medical Research Department of Health Research (MoHFW) New Delhi, India

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Equine Stem Cells. Sources, Processing, Expansion, Storage and Shipping

Equine Stem Cells. Sources, Processing, Expansion, Storage and Shipping Equine Stem Cells Sources, Processing, Expansion, Storage and Shipping Sean Owens, DVM, Diplomate ACVP Medical Director, UC Davis Veterinary Regenerative Medicine Laboratory What is a Stem Cell and What

More information

Stem Cell Therapy. Treat your pain, improve your lifestyle and look after your wellbeing. What are stem cells?

Stem Cell Therapy. Treat your pain, improve your lifestyle and look after your wellbeing. What are stem cells? (02) 9824 3044 LIVERPOOL NSW 2170 Stem Cell Therapy Treat your pain, improve your lifestyle and look after your wellbeing What are stem cells? Stem cells are cells that can differentiate into other types

More information

[Indian Stem Cell Banking Market: Trends & Opportunities (2012-2017)]

[Indian Stem Cell Banking Market: Trends & Opportunities (2012-2017)] [Indian Stem Cell Banking Market: Trends & Opportunities (2012-2017)] Executive Summary Stem Cells have a remarkable ability to develop in various body cells of a human. These occur in the earliest stages

More information

CPT Codes for Bone Marrow Transplant January 2015 James L. Gajewski, MD

CPT Codes for Bone Marrow Transplant January 2015 James L. Gajewski, MD The blood and marrow transplant field has 15 dedicated CPT codes. These CPT codes can be categorized into three groups: 1. Collection Codes 2. Cell Processing Codes 3. Cell Infusion Codes Collection Codes

More information

Collecting cord blood to save and improve lives. Rebecca Roberts

Collecting cord blood to save and improve lives. Rebecca Roberts Collecting cord blood to save and improve lives Rebecca Roberts Cells4Life Introduction to stem cells Why cord blood is important Legislation Cells4Life Cord blood collection What is a stem cell? Cells

More information

Standard Operating Procedure. Clinical Trial Authorisation

Standard Operating Procedure. Clinical Trial Authorisation Standard Operating Procedure for Clinical Trial Authorization Scope This SOP has been written to describe the procedure undertaken to apply for Clinical Trial Authorisation from Competent Authorities in

More information

Transmedcon 2014. Ahmedabad, Gujarat November 14-16, 2014

Transmedcon 2014. Ahmedabad, Gujarat November 14-16, 2014 FACT Accreditation for Cord Blood Banks and Cellular Therapy Nadim Mahmud, MD, PhD Associate Professor of Medicine Division of Hematology/Oncology Director, Hospital Stem Cell Laboratory Blood & Marrow

More information

[DOCKET NO.96N-0002] DRAFT

[DOCKET NO.96N-0002] DRAFT [DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,

More information

Future Health Technologies. From Academia to Industry The Stem Cell Challenge. Roger J. Dainty MBE FIScT UK Managing Director

Future Health Technologies. From Academia to Industry The Stem Cell Challenge. Roger J. Dainty MBE FIScT UK Managing Director Future Health Technologies From Academia to Industry The Stem Cell Challenge Roger J. Dainty MBE FIScT UK Managing Director How Did I Get Here? Working as a Research Medical Technician (Birmingham University

More information

The Cell Therapy Catapult UK Clinical Trials Database

The Cell Therapy Catapult UK Clinical Trials Database May 2015 The UK Clinical Trials Database covers cell therapy clinical trial activity that the Cell Therapy Catapult believes to be ongoing in the UK as of May 2015. It supersedes the database of April

More information

Overview of Phase 1 Oncology Trials of Biologic Therapeutics

Overview of Phase 1 Oncology Trials of Biologic Therapeutics Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of

More information

Ask Us About Clinical Trials

Ask Us About Clinical Trials Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing

More information

Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age. Dr Roisin Deane Cell Care Australia Pty Ltd

Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age. Dr Roisin Deane Cell Care Australia Pty Ltd Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age Dr Roisin Deane Cell Care Australia Pty Ltd What are Gestational Stem Cells? Stem cells isolated from the gestational tissues

More information

San Diego Stem Cell Treatment Center Frequently Asked Questions

San Diego Stem Cell Treatment Center Frequently Asked Questions San Diego Stem Cell Treatment Center Frequently Asked Questions What is a Stem Cell? A stem cell is basically any cell that can replicate and differentiate. This means the cell can not only multiply, but

More information

The therapies are focused in cardiovascular, orthopedics and neurological indications.

The therapies are focused in cardiovascular, orthopedics and neurological indications. 1 2 CescaTherapeutics is (to our knowledge) the first company to integrate all of the essential: 1. Cell friendly devices, 2. Proprietary cell formulations, and Strict clinical steps to ensure the autologous

More information

Stem cells from Cord Blood: Myths, reality and potential. Elisabeth Semple, PhD Scientific Director Cells for Life Cord Blood Institute

Stem cells from Cord Blood: Myths, reality and potential. Elisabeth Semple, PhD Scientific Director Cells for Life Cord Blood Institute Stem cells from Cord Blood: Myths, reality and potential Elisabeth Semple, PhD Scientific Director Cells for Life Cord Blood Institute Learning objectives Understand the current usage of stem cells from

More information

Pl I enary Tr T anslational Medicine April 30, 2015

Pl I enary Tr T anslational Medicine April 30, 2015 Plenary I Translational Medicine April 30, 2015 HBO in Hematopoietic Stem Cell Transplantation: Lessons Learned Omar Aljitawi, MD Hematology/Oncology Hematology and Transplantation (HAT) Laboratory Pathology

More information

UMBILICAL CORD BLOOD BANKING A guide for parents

UMBILICAL CORD BLOOD BANKING A guide for parents UMBILICAL CORD BLOOD BANKING A guide for parents 2 nd EDITION INTRODUCTION The cells contained in the umbilical cord blood have therapeutic value for the treatment of blood disorders and immune diseases.

More information

Top Ten Things to Know About Stem Cell Treatments

Top Ten Things to Know About Stem Cell Treatments Top Ten Things to Know About Stem Cell Treatments Many clinics that are offering stem cell treatments make claims about what stem cells can and cannot do that are not supported by our understanding of

More information

House Resolution No. 37

House Resolution No. 37 california legislature regular session House Resolution No. Introduced by Assembly Member Hill August, House Resolution No. Relative to umbilical cord blood banking. WHEREAS, Since the first umbilical

More information

Phone: +44 20 8123 2220 Fax: +44 207 900 3970 office@marketpublishers.com http://marketpublishers.com

Phone: +44 20 8123 2220 Fax: +44 207 900 3970 office@marketpublishers.com http://marketpublishers.com Global Stem Cell Umbilical Cord Blood (UCB) Market (Storage Service, Therapeutics, Application, Geography) - Size, Share, Global Trends, Analysis, Opportunities, Growth, Intelligence and Forecast, 2012-2020

More information

Hematologic Malignancies/Stem Cell Transplantation Program Clinical Section UCLA Health System Los Angeles, CA 90095

Hematologic Malignancies/Stem Cell Transplantation Program Clinical Section UCLA Health System Los Angeles, CA 90095 Hematologic Malignancies/Stem Cell Transplantation Program Clinical Section UCLA Health System Los Angeles, CA 90095 CS 6.4 DIAGNOSIS AND MANAGEMENT OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE Location:

More information

Bone Marrow/Stem Cell Transplant

Bone Marrow/Stem Cell Transplant Blue Distinction Centers for Transplants Program Selection Criteria for 2010 Mid-Point Designations To qualify as a Blue Distinction Center for Transplants (), each facility must satisfy s quality based

More information

Hippocrates, Cords and Quality

Hippocrates, Cords and Quality Hippocrates, Cords and Quality Transfusion Medicine Resident Education Seminar April 3,2012 Renee Naiman, Director, Quality and Regulatory Affairs Overview -Brief update of cord blood history and usage.

More information

5 Frequently Asked Questions About Adult Stem Cell Research

5 Frequently Asked Questions About Adult Stem Cell Research 5 Frequently Asked Questions About Adult Stem Cell Research Stem cells are often referred to in the sociopolitical realm with some level of controversy and beyond that, some level of confusion. Many researchers

More information

PACT Web Seminar July 19, 2007

PACT Web Seminar July 19, 2007 PACT Web Seminar July 19, 2007 Phyllis I. Warkentin, MD Professor, Pathology and Pediatrics University of NE Medical Center Medical Director Chairman, Accreditation Program Foundation for the Accreditation

More information

Do you have anything to add? If so, I d love to hear from you! Jessica Robinson Conference Manager Life Sciences @jessbiopharma

Do you have anything to add? If so, I d love to hear from you! Jessica Robinson Conference Manager Life Sciences @jessbiopharma 1 Who is the most influential figure in cord blood around the world? What is the biggest challenge to overcome in the use of cord blood as a source of stem cells? We asked 10 leading experts in the cord

More information

CIGNA HEALTHCARE COVERAGE POSITION

CIGNA HEALTHCARE COVERAGE POSITION CIGNA HEALTHCARE COVERAGE POSITION Subject Umbilical Cord Blood Banking Table of Contents Coverage Position... 1 General Background... 1 Coding/Billing Information... 3 References... 3 Revised Date...

More information

The CIBMTR Audit Program

The CIBMTR Audit Program The CIBMTR Audit Program Amy Hays and Krista Sullivan November 7, 2008 Objectives Audit rationale and goals Overview of audit program Audit process Audit follow-up Why are audits performed? Audit Rationale

More information

What we will discuss today

What we will discuss today Umbilical cord blood banking It s Utility? Dr. Nita Radhakrishnan Pediatric Hematology Oncology Unit, Sir Ganga Ram Hospital, New Delhi What we will discuss today What are stem cells? What are the sources

More information

umbilical cord blood banking A guide for parents

umbilical cord blood banking A guide for parents umbilical cord blood banking A guide for parents 2 nd Edition 2016 This guide has been elaborated by the Council of Europe European Committee on Organ Transplantation (CD-P-TO). For more information, please

More information

CHAPTER 1 BACKGROUND AND CORD BLOOD BANK (CBB) ORGANIZATION

CHAPTER 1 BACKGROUND AND CORD BLOOD BANK (CBB) ORGANIZATION CHAPTER 1 BACKGROUND AND CORD BLOOD BANK (CBB) ORGANIZATION Chapter 1 BACKGROUND AND CORD BLOOD BANK (CBB) ORGANIZATION 1.1 OVERVIEW OF THE CORD BLOOD TRANSPLANTATION STUDY Bone marrow transplantation

More information

Hematopoietic stem and progenitor cell transplants: regulation and accreditation

Hematopoietic stem and progenitor cell transplants: regulation and accreditation Pediatr Transplantation 2003: 7 (Suppl. 3): 101 108 Printed in UK. All rights reserved Copyright Ó 2003 Blackwell Munksgaard Pediatric Transplantation ISSN 1398-2265 Hematopoietic stem and progenitor cell

More information

How To Support Umbilical Cord Blood Stem Cell Research

How To Support Umbilical Cord Blood Stem Cell Research Cauley O. Gieb Advanced Health Law HLP Article Umbilical Cord Blood Stem Cell Research: The Proof is in the Cord Today advances in science seem to gain the most recognition and support when the subject

More information

A Public Cord Blood Bank for South Africa? i

A Public Cord Blood Bank for South Africa? i No. 42/2007 A Public Cord Blood Bank for South Africa? i By Dr Robert Crookes MBChB (Wits), Dip. Internal Medicine (American Board of Internal Medicine, USA) Transfusion Medicine Consultant. South African

More information

UMBILICAL CORD BANKING. (formerly Unistem Biosciences Pvt.Ltd.)

UMBILICAL CORD BANKING. (formerly Unistem Biosciences Pvt.Ltd.) UMBILICAL CORD BANKING (formerly Unistem Biosciences Pvt.Ltd.) INITIATIVES OF CELLUGEN BIOTECH PVT.LTD. (formerly Unistem Biosciences Pvt.Ltd.) UMBILICAL CORD BANKING UMBILICAL CORD STEM CELL THERAPY Stem

More information

Hematopoietic Stem Cell Transplantation. Imad A. Tabbara, M.D. Professor of Medicine

Hematopoietic Stem Cell Transplantation. Imad A. Tabbara, M.D. Professor of Medicine Hematopoietic Stem Cell Transplantation Imad A. Tabbara, M.D. Professor of Medicine Hematopoietic Stem Cells Harvested from blood, bone marrow, umbilical cord blood Positive selection of CD34 (+) cells

More information

11/10/2011. History of CBUs. 10-CBA providing access to unlicensed cord blood units. The FDA s involvement. The FDA s involvement, cont.

11/10/2011. History of CBUs. 10-CBA providing access to unlicensed cord blood units. The FDA s involvement. The FDA s involvement, cont. History of CBUs First CBU transplant done in 1988 10-CBA providing access to unlicensed cord blood units Using the NMDP IND to access unlicensed cord blood units Amy Hays, Sr. Clinical Research Specialist,

More information

»medical programs and services. transfusion medicine fellowship program

»medical programs and services. transfusion medicine fellowship program »medical programs and services transfusion medicine fellowship program new york blood center transfusion medicine fellowship program» Experience at one of the largest nonprofit, community-based blood centers

More information

How To Expand Hematopoietic Stem Cells

How To Expand Hematopoietic Stem Cells Purification and Expansion of Hematopoietic Stem Cells Based on Proteins Expressed by a Novel Stromal Cell Population Our bodies are constantly killing old, nonfunctional, and unneeded cells and making

More information

Umbilical Cord Blood Transplantation

Umbilical Cord Blood Transplantation Umbilical Cord Blood Transplantation V Rocha MD, PhD Hopital Saint Louis, Paris University 7 CIBMTR Milwaukee Umbilical Cord blood transplantation Background History Clinical results in children and adults

More information

Patient Handbook on Stem Cell Therapies

Patient Handbook on Stem Cell Therapies Patient Handbook on Stem Cell Therapies Appendix I of the Guidelines for the Clinical Translation of Stem Cells www.isscr.org 2008, International Society for Stem Cell Research 2 Introduction We have all

More information

The Facts about Cord Blood

The Facts about Cord Blood The Facts about Cord Blood Dear Future Mom and/or Dad, All of us at CorCell would like to give you a big CONGRATULATIONS on your new baby! Now that you are expecting, you have probably heard about saving

More information

CORD BLOOD TRANSPLANTATION: PAST, PRESENT AND FUTURE

CORD BLOOD TRANSPLANTATION: PAST, PRESENT AND FUTURE CORD BLOOD TRANSPLANTATION: PAST, PRESENT AND FUTURE Dennis M. Todd, Ph.D. The New Jersey Cord Blood Bank a Division of Bergen Community Regional Blood Center Montvale, NJ Hematopoietic Stem Cell Transplantation

More information

OUR JOURNEY THROUGH THE YEARS

OUR JOURNEY THROUGH THE YEARS The King Faisal Specialist Hospital and Research Centre Experience in Hematology, Oncology and Bone Marrow Transplantation OUR JOURNEY THROUGH THE YEARS REGGIE BELKHEDIM A Brief Overview: King Faisal Specialist

More information

UMBILICAL CORD BLOOD BANKING. A guide for parents

UMBILICAL CORD BLOOD BANKING. A guide for parents UMBILICAL CORD BLOOD BANKING A guide for parents This guide has been elaborated by the Council of Europe European Committee on Organ Transplantation (CD-P-TO). For more information, please visit https://go.edqm.eu/transplantation.

More information

International Stem Cell Registry

International Stem Cell Registry International Stem Cell Registry Importance of Stem Cells Stem cells are model systems for the study of development and disease. Pluripotent stem cells offer new tools for drug design and discovery. Pluripotent

More information

It s not something you want to think about, but it s something you want to prepare for.

It s not something you want to think about, but it s something you want to prepare for. It s not something you want to think about, but it s something you want to prepare for. StemCyte cord blood banking offers your family a new lifesaving treatment alternative Why Bank Take the once-in-alifetime

More information

Therapeutic Treatment Options: Chronic Blood Transfusions Bone Marrow Transplantation. Marianne E. McPherson Yee, MD, MSc

Therapeutic Treatment Options: Chronic Blood Transfusions Bone Marrow Transplantation. Marianne E. McPherson Yee, MD, MSc Therapeutic Treatment Options: Chronic Blood Transfusions Bone Marrow Transplantation Marianne E. McPherson Yee, MD, MSc Sickle Cell Treatment Options Supportive Care Newborn Screen PCN Immunizations Education

More information

Current Issues in Stem Cell Technologies. Lance D. Trainor, MD OneBlood, Inc.

Current Issues in Stem Cell Technologies. Lance D. Trainor, MD OneBlood, Inc. Current Issues in Stem Cell Technologies Lance D. Trainor, MD OneBlood, Inc. Objective: The big picture of stem cell therapy Outline: Relevant definitions History of Stem Cell Therapy Hematopoietic Stem

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 Tetsuya Kusakabe, Ph.D., M.P.H. Review Director Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA),

More information

PART I. SECTION 1. The legislature finds that an estimated. 128,000,000 Americans suffer from the crippling economic and

PART I. SECTION 1. The legislature finds that an estimated. 128,000,000 Americans suffer from the crippling economic and HOUSE OF REPRESENTATIVES TWENTY-FOURTH LEGISLATURE, 2007 STATE OF HAWAII A BILL FOR AN ACT RELATING TO MEDICAL RESEARCH. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII: PART I SECTION 1. The legislature

More information

A Genetic Analysis of Rheumatoid Arthritis

A Genetic Analysis of Rheumatoid Arthritis A Genetic Analysis of Rheumatoid Arthritis Introduction to Rheumatoid Arthritis: Classification and Diagnosis Rheumatoid arthritis is a chronic inflammatory disorder that affects mainly synovial joints.

More information

CMC Writing for IND Applications. David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop

CMC Writing for IND Applications. David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop CMC Writing for IND Applications David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop CMC Writing for IND Applications ~Outline~ What is the CMC section? Who writes the CMC section?

More information

OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM

OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM Ministry Of Health National Institute of Hematology and Blood Transfusion OVERVIEW OF CURRENT STATUS OF STEM CELL TRANSPLANTATION IN VIETNAM Prof. Nguyen Anh Tri MD., PhD., Director of NIHBT (Vietnam)

More information

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this

More information

Saving Your Baby s Cord Blood

Saving Your Baby s Cord Blood Saving Your Baby s Cord Blood An Important Pregnancy Decision 1-888-CORD BLOOD HEALTHY FUTURES ARE Born at CBR For every parent who wishes they could do more to protect their family s health, there s Cord

More information