An Introduction to the Canadian OneMatch Public Cord Blood Bank

Transcription

1 An Introduction to the Canadian OneMatch Public Cord Blood Bank Tanya Petraszko MD FRCPC With thanks to: Dr. Heidi Elmoazzen, Director, OneMatch Public Cord Blood Bank

2 Cord Blood Project Team Sue Smith Executive Director, Stem Cells Dr. Heidi Elmoazzen Project Director Dr. David Allen Medical Director, Consultant Dr. Tanya Petraszko Medical Director, Consultant Mike Halpenny Sr. Project Manager, Manufacturing Karen Mostert Manager, Recruitment & Collections Todd Campbell Project Manager Cheryl Earl Laboratory Technologist Colleen Bruneau Project Coordinator Lily Pepper Activations Administrator 2

3 Overview Overview of the need for stem cells HLA diversity OneMatch Public Cord Blood Bank model Cord blood banking process Current activities and next steps 3

4 Stem Cells Two types of stem cells Embryonic Adult Three main sources of (hematopoietic) adult stem cells Bone marrow Peripheral blood mobilization Umbilical cord blood 4

5 Number of Patients Canadian Patient Searches Demand and Need Continues to Increase /05 05/06 06/07 07/08 08/09 09/10 10/11 11/12 YTD Total 5

6 Canadian Stem Cell Recipients Canadian Unrelated Transplants /03 03/04 04/05 05/06 06/07 07/08 08/09 09/10 10/11 11/12 YTD International Donor Canadian Donor 6

7 Canadian Patients Transplanted Using Cord Blood Stem Cells Cord Blood Transplants /03 03/04 04/05 05/06 06/07 07/08 08/09 09/10 10/11 11/12 Hema-Quebec Cords Cord Blood Transplants 7

8 Need for Additional Stem Cells OneMatch is an active member of the International Network of stem cell registries behalf of all Canadian patients needing a stem cell match, we search and have access to:] 18.9M potential adult donors from 66 registries in 49 countries; 523K public cords from 44 cord blood banks in 30 countries. BMDW, April 09,

9 Need for Additional Stem Cells However only able to find matches for about 50% of patients harder to find matches in many ethnic groups due to under-representation on registries worldwide. 9

10 Need for Additional Stem Cells US National Marrow Donor Registry: AABB million donors on registry Adds 1 million per year to registry Rate of 8/8 match (HLA A B C DRB1) Caucasian 80% Asian 30 40% South Central American Black 15% Due to under representation in donor pool AND Increased diversity in the minority groups 10

11 Need for Increased HLA Diversity Increasing donor number has less impact vs pre 2004 Duplication of common haplotypes Need to increase less common haplotypes even more so than common ones Eg assume equal registry size probability of match if African ancestry = 30% vs 60% in non Africans Due to HLA diversity WITHIN the population NMDR

12 Cords and Ethnic Diversity Higher likelihood of match as only 6/6 required HLA A B DR US NBMDR data 150,000 CBU and add 25,00 per year Likelihood of 6/6 match European descent: 15% adult recipient, 35% child Likelihood of 4/6 match 75% in ALL adult populations Virtually 100% in children in all ethnic groups 12

13 Current Canadian Situation In Canada, there are 10 private cord blood banks and 3 public cord blood banks. The 3 public cord banks are:. 1. Héma-Québec 2. Alberta Cord Blood Bank 3. The Victoria Angel Registry of Hope 13

14 Need for a National Public Cord Blood Bank continued significant increase in demand Canada s unique and large ethnic diversity Uncoordinated, multiple banks cannot meet the need for a HLA diverse inventory that is required for Canadian patients. Only G8 country to not have one All cord blood units supplied by CBS for unrelated transplant are imported from international sources. The cost of importing cord blood units continues to increase $42,000 ea. 14

15 Benefits of Cord Blood Cord blood has distinct advantages over bone marrow or PBSCs: More lenient HLA matching requirements With adequate cell dose outcomes similar for 4/6 vs 6/6 HLA matches Units are available immediately 1 day 2wks vs 3 10 mos for adult stem cells Lower risk of graft-vs.-host disease (GvHD) Naïve cells with long telomers Minimal risk to donor (mother and baby) 15

16 OneMatch Public Cord Blood Bank A centralized, national model for cord blood able to meet the needs of all Canadians addressing the patient needs of each province, including ensuring local (hospital) timely access Focus on ethnic diversity Canadian Blood Services is well-positioned to provide an HLAdiverse, searchable, accredited cord blood bank Canada joins all other countries in the G8 by becoming increasingly self-reliant for domestic use International contribution 16

17 Benefits of a National Public Cord Blood Bank Reduce Canada s dependency on international sources for cord blood, global supplier instead of simply a net importer Cords supplied free to Canadian transplant centers Confidence and consistency in product quality and safety Quality varies across centers worldwide A national, centralized model single point of access for physician searches facilitates international exchanges of cord blood units 17

18 Benefits of a National Public Cord Blood Bank Gain efficiencies by having one national bank for the country avoid expense of duplicate effort and infrastructure Leverages Canada s ethnic and racial demographics Benefits both Canadian and international patients Stimulates stem cell research in Canada provides support for translating Canada s leading edge research into cellular therapies 18

19 Canadian Datacord Data What are Canadian TC selecting? Adults 2010 average TNC per single cord recipient = 2.7 X 10 9 (range ) n = 7 average TNC per double cord recipient = 4.60 x 10 9 (range ) n = 3 Adults 2011 average TNC per single cord recipient = 2.70 x 10 9 (range ) n = 12 average TNC per double cord recipient= 2.70 x 10 9 (range ) n = 3 Paediatrics 2010 average TNC per single cord recipient = 1.77 x10 9 (range ) n = 7 average TNC per double cord recipient =3.20 x 10 9 (range ) n = 3 Paediatrics 2011 average TNC per single cord recipient = 1.88 x 10 9 (range ) n = 16 average TNC per double/triple cord recipient = 4.04 x 10 9 (range ) n = 6 Infants 2011 less than 2years average TNC per single cord recipient = 1.26 x10 9 (range ) n = 11 double cord recipient TNC = 2.35 x

20 Double Cords: Still high TNC Adults 2010 average TNC per each CBU = 1.69 x 109 (range ) Adults 2011 average TNC per each CBU = 1.35 x 10 9 (range ) Pediatrics 2010 average TNC per each CBU = 1.21 x 10 9 (range ) Pediatrics 2011 average TNC per each CBU = 1.86 x 10 9 (range ) Infants 2011 TNC for each CBU = 1.27 x 10 9 and x

21 TNC threshold: International Perspective Center or Organization Minimum Volume* Minimum TNC* Plan to increase threshold* Different cutoff for ethnic non dominant* CD 34+* Houston MD Anderson 40 ml 0.9 X X New York 40 ml 1.4 X Florida Life Cord 40 ml 1.5 X X 10 9 Cleveland Switzerland X Spain X Geneva X X 10 9 Paris X 10 7 Anthony Dolan CBB # X X 10 9 Barcelona # 2.0 X x 10 6 if TNC x 10 9 Eurocord 1.0 X 10 9 Taiwan 80 ml 0.8 x

22 OMPCBB 1.5 x 109 TNC per banked cord blood unit 22

23 Official Announcement March 14, 2011 Ministers of Health announce Canada's first national, publiclyfunded umbilical cord blood bank $48 million investment over eight years. $12.5M of the $48M will be raised over three years by Canadian Blood Services fundraising campaign. April 1, 2011 OneMatch Public Cord Blood Bank project begins in Ottawa, as per approved model by the Ministers of Health July 2012 Begin collections in Ottawa for process validation April 2, 2013 Go live! Ottawa Hospital 23

24 Guiding Principles Canadian Blood Services will establish and operate a national, public cord blood bank that will: be accessible to all Canadian patients, at no charge; be accessible to international patients; be a source for cord blood units in addition to international registries; operate in compliance with regulatory and accreditation standards, to ensure the safety and efficacy of the product for therapeutic use; be publicly funded through the provincial and territorial governments (excluding Québec); contain an HLA diverse inventory to reflect the ethnic make up of the Canadian population, to ensure that ethnic minorities have access to high-quality cord blood; promote research efforts that contribute to improved clinical care, by providing to Canadian researchers stem cells that cannot be used for transplantation; and, operate in the highest ethical manner, respecting both the rights and needs of Canadian infants and mothers, and the rights and needs of patients. In keeping with its mission, Canadian Blood Services will operate the cord blood bank in a manner that gains the trust, commitment and confidence of all Canadians by providing a safe, secure, costeffective, affordable and accessible supply of quality cord blood units. 24

25 OneMatch Public Cord Blood Bank Model Includes at least four collection cities and two manufacturing facilities for processing, storage and distribution. We will also develop cord blood collection kits that can be sent to targeted areas outside of cities listed below to reach Aboriginal communities Canadian Blood Services OneMatch National Public Cord Blood Bank (inventory of 20,000 units within 8 years*) Medical and Scientific Advisory Committee Searching, Matching OTTAWA Manufacturing Facility (April 2, 2013) EDMONTON Manufacturing Facility (2014) CBS Support HLA Testing Transmissible Disease Testing CBS Research Ethics Committee (units unsuitable for transfusion) Marketing & Recruitment *Optimal size of a national cord blood inventory is currently estimated to be approximately 20,000 units, which can be achieved within eight years using this Model. Canadian Transplant Programs International Registries OTTAWA Collection Hospital(s) (April 2, 2013) TORONTO Collection Hospital(s) (2014) EDMONTON Collection Hospital(s) (2014) VANCOUVER Collection Hospital(s) (2014) Canadian Research Scientists 25

26 Cord Blood & Research Approximately 20% to 40% of the cord blood units collected are of sufficient volume and/or cell count to be used for transplantation. Donors will have the option to designate their cord for research in Canada if it is not suitable for transplantation. Working with stakeholders to ensure a comprehensive system is in place for Canadian researchers to access cord units in a rational, fair and transparent manner 26

27 Potential Uses of Stem Cells 27

28 Cord Blood Banking Process Seven key processes for cord blood will include capturing and centralizing data on a per unit basis for traceability, searching and matching, information management, ad-hoc queries, reporting, data export and modeling for optimization. Awareness Recruitment Collection Receiving, Assessing, Processing, Testing, Storage Searching, Matching Distribution Transplant, Follow-up Stem Cell Application Solution 28

29 Awareness Marketing Objectives 1. To develop strategy to raise awareness of the public cord blood bank among prospects to facilitate recruitment 2. To implement tactics to support recruitment 3. To develop strategy for donor recognition 29

30 Recruitment Our target group is specific and localized, i.e., healthy pregnant women who plan to deliver at the designated collection hospitals: Discussions begin during the antenatal period with their health care professional Education, information gathering, questions (becoming informed of process in advance of day of delivery) Arrive on special day with Permission to Collect form ready No advance registration 30

31 Collection Three Collection Methods 1. Ex-utero: Fully supported by CBS OMPCBB designated staff 2. In-utero (supported): All aspects of collection, labelling, packing/shipping by hospital staff CBS OMPCBB Nurse Specialist for maternal interview 3. In-utero(non-supported): Entire process completed by hospital staff. This model is intended for future remote sites e.g. northern Canada. The Ottawa Hospital April 2, 2013 General Campus: Ex-utero Civic Campus: In-utero (supported) 31

32 Manufacturing Current Resources Ottawa Stem Cell Manufacturing Facility (40 Concourse Gate): Peripheral Blood Apheresis / Bone Marrow: Processing, testing, storage, distribution New Manufacturing Area 2004 Four manufacturing areas 2000 sq. ft. FACT Accredited / GMP Guidelines Staffing: Charge Technologists and MLTs Manufacturing Equipment 32

33 Receiving & Assessing From collection site to manufacturing facility Process control / inventory control / tracking CBS Transport / selected courier Assessing: Acceptability criteria Volume, blood cell counts, visual inspection, pre- manufacturing sample Maternal blood samples: TD testing Cord samples: genetic screening for hemoglobinopathies 33

34 Processing Sepax System Fully-automated, mobile, GMP compliant system for the efficient and reproducible processing of umbilical cord blood, bone marrow and peripheral blood Hands-free operation automated, closed, sterile system Quick, accurate data tracking Consistently high mononuclear cell recoveries 34

35 Quality Control Testing Blood cell counts (Pre and Post) Purity, Potency, Safety Purity: Microbiology Potency: Stem Cell Counts Flow Cytometer (CD34+ count) CFU Assay (stem cell culture) Safety: Genetic screening, infectious disease testing QC samples storage 35

36 Cryopreservation Volume reduced cord blood unit Cryo-protectant added (DMSO) Controlled rate freezing using ThermoGenesis BioArchive freezer Holds up to 3,636 units Liquid nitrogen storage (-196 C) Inventory controlled / tracked Must be stored within 48 hours of collection; can be stored indefinitely 36

37 Searching and Matching Listed on OneMatch Registry Banked inventory of cord blood units Cords listed, searched and requested Searched both nationally and internationally OneMatch Stem Cell National Systems Solution (IT system) Physicians / Clinical Transplant sites request OneMatch banked cord blood unit Build on current OneMatch process 37

38 Distribution Requested Cord Blood for Transplant Manufacturing selects, releases, packs and ships Transport courier 38

39 Transplant and Follow-up Transplant Follow-up: Outcome Measurement Build upon the current OneMatch process Infusion Reactions Engraftment Data 100 day follow-up Family History Genetic 39

40 Scope and Timelines The Canadian Blood Services OneMatch Public Cord Blood Bank will consist of collection sites (hospitals) in Ottawa, Toronto, Edmonton and Vancouver, with processing and storage sites at our two existing stem cell manufacturing facilities in Ottawa and Edmonton. The goal is to reach a minimum of 20,000 cord blood units in storage for transplantation by March 31, 2019 eight year period beginning April 1, Phase I of the cord blood bank will be operational in Ottawa in April 2, 2013, and in the remaining sites, Phase II, in FY 2011/12 FY 2012/13 FY 2013/14 FY 2014/15 Ottawa Collection & Manufacturing Edmonton Collection & Manufacturing Vancouver Collection Toronto Collection PHASE I PHASE II PHASE II PHASE II 40

41 Manufacturing Facility Renovations 40 Concourse Gate Ottawa LN Auto-fill System Installed Storage Room Renovations Completed Equipment, room temperature/humidity monitoring implemented Receipt and installation of key pieces of equipment 41

42 Edmonton Facilities renovations Human resources Other Cord Blood Activities Regulation/Accreditation Health Canada Registration FACT/NetCord Accreditation AABB Accreditation Information Technology SAP: Selected Solution Customer Support Provided by our National Contact Centre and OMPCBB Team 42

43 Other Cord Blood Activities Fundraising First annual charity golf tournament held September 22, 2011 Second annual charity hockey game held March 19, 2012 Sponsorship engagement with key corporations and other organizations, ongoing Phase II Hospital Selection Planning Based on birth statistical data and geographic location, 13 hospitals in Vancouver, Edmonton and Toronto have been identified Ethnicity data on the population surrounding these hospitals collected to further narrow down the selection of potential collections sites for Phase II RFI imminent 43

44 Next Steps to Go-live, April 2, 2013 Infrastructure Ottawa Facility Renovations Equipment Installation & training Documentation Processes Data Requirements Procedures (ie, SOPs) Forms (ie, Consent) Hospital Readiness Agreement (MOU) Renovations Communications Validation Begin collecting in Ottawa to validate/test all processes and equipment 44

45 Cord Blood Project Support Team First Name Last Name Title First Name Last Name Title Lisa Martin Charge Technologist Donna Perron Stem Cell Technologist Berna Mendoza Technologist Lin Yang Senior Research Assistant Paul Waite IT Consultant Alison Baizana Director, Risk and Insurance Management Janet Parks Case Manager, OneMatch Cilla Perry Manager, Research & Development Sandra Balestra Senior Administrative Assistant Virginia Gaffney Marketing Mgr, OneMatch & Automated Collections Jennifer Biemans Director, Regulatory Affairs Yves Garcia Director, Stem Cells National Systems Solutions John Bromley National Manager, Public Affairs Gail Mingie Coordinator, Privacy and Access to Information Dr. Locksley McGann Scientific Advisor Wendy Lowthers Associate, Reporting, Regulatory Affairs Scott Burton Contract Coordinator Jennifer Philippe Director, OneMatch Stem Cell and Marrow Network Kathy Ganz Manager, Quality Assurance Lisa Potter Process and Risk Management Consultant Melanie Griffin Legal Counsel Shelley Price Manager, Submissions, Regulatory Affairs Robert Kelly Manager, Facilities Kathleen Priestman Associate, Privacy and Access to Information Todd Fenton Supervisor, Supply Services Dale Rosborough A/Project Manager, Business Continuity Jason Oliver Business Systems Analyst II Annie Barrette Communications Specialist Janet Parks OneMatch Program Integration Jeannette Venedam Subject Matter Expert, Business Lead Brian Wand Purchasing Lucie Sabourin A/Director, Records Management Rubina St. Louis Financial Analyst Margaret Miedema Director, Major Gifts and Campaign Michael den Admirant Associate, Validation Brenda Letcher Laboratory Technologist III, Supervisor Gilles Rancourt Director, Logistics Alexandra Wilgosh Project Manager, Donor Testing Gordon Sutherland Field Logistics Manager, NEON Dr. Antonio Giulivi Scientific Advisor Mary Mainella Manager, Human Resources Jean Landreville Manager, Distribution David Strachan Facilities Coordinator Sophie Charge Director, Research & Education Dr. Sofia Tavoularis Director, HLA Jim Jeang Interactive Marketing Manager Denny Michaud Manager, Customer Relations (NCC) Donna Killeen Director, Corporate Portfolio Management Christopher Mulders Acting NDAS Team Lead Ryan Melnyk Biomedical Technologist/NDAS Specialist Rosanne Dawson Legal Counsel Judie Leach Bennett Executive Director, Research & Education Steve Harding Executive Director, Development Margaret Miedema Director, Major Gifts & Campaign Ramin MaysamiAzad Biomedical Technologist Elaine Ashfield Executive Director, PRIMO & Chief Privacy Officer John Soucie Biomedical Technologist Nancy Robitaille Document Facilitator

46 Thank you 46