Canadian Blood Services National Public Cord Blood Bank

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1 Canadian Blood Services National Public Cord Blood Bank Dr. Heidi Elmoazzen Director, National Public Cord Blood Bank

2 Hematopoetic Stem Cells Hematopoetic stem cells are not yet mature (undifferentiated) cells that can divide and develop into any one of the three main types of cells found in the blood: Red blood cells, which carry energy-giving oxygen from the lungs to the entire body; White blood cells, important immune cells that play an important role in fighting bacteria and viruses that cause infection; and Platelets, which help blood to clot when bleeding occurs. 2

3 3 How are stem cells collected?

4 Stem Cell Transplants Adults and Children With Life Threatening Diseases Leukemia Aplastic Anemia Immune Dysfunctions Genetic Disorders 4

5 OneMatch Stem Cell and Marrow Network Canadian Blood Services national public cord blood bank is part of the OneMatch Stem Cell and Marrow Network, which is a national program that: recruits healthy, unrelated, volunteer blood stem cell donors conducts searches for patients who need an unrelated blood stem cell transplant coordinates the collection and delivery of blood stem cells when a match is found

6 Why Unrelated Donors? HLA Typing: inherited genetic markers Only 25% of patients have a match in family Unrelated donors are often from the same ethnic group as the patient Leila, OneMatch Registrant & whole blood donor 6

7 OneMatch Fast Facts October 2013 Searchable donors: 324,092 Canadian Transplant Centres: 12 Canadian Collection Centres: 8 International Registries: 71 Over 21,804,092 registrants worldwide International Cord Blood Banks: 48 Over 590,426 umbilical cord blood units Francis, OneMatch Registrant 7

8 WHY build a National Public Cord Unacceptable that we can only find matches for approximately 50% of our Canadian patients. Blood Bank now? This valuable resource is being discarded as medical waste. 8

9 March 14, 2011 Official Announcement Ministers of Health announce Canada's national, publicly-funded umbilical cord blood bank $48 million investment over eight years. The provincial and territorial governments recognized this as an important health need and signed a contract to provide operational funding for this new initiative to be led by Canadian Blood Services. Canadian Blood Services is committed to raise $12.5 million needed to cover start-up costs. April 1, 2011 National Public Cord Blood Bank project began in Ottawa, as per approved model by the Ministers of Health September 30, 2013 Go-live in Ottawa! Mid Go-live in Edmonton, Vancouver and Brampton (GTA) 9

10 Number of Patients Canadian Patient Searches- The demand and need continues to increase / / / / / / / / /2013 Total 10

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

12 Number of Cord Units Procured Cord Units Selected for Canadian Patients / / / / / / / /2013 Fiscal Year International Cords Hema-Quebec Cords 12

13 Number of Cord Blood Units provided for Unrelated Transplantation (Data courtesy of WMDA) Number of cord blood units provided for unrelated transplantation Number of HPC Cord shipped 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1, , ,093 Year No information provided Units provided for adults Units provided for children 13

14 Caucasian Patient Searches Caucasian / / / / / /14 Number of Patients 2008/ / / / / /14 Caucasian

15 First Nations, Métis, Inuit Patient Searches First Nation, Metis, Inuit / / / / / /14 Number of Patients 2008/ / / / / /14 First Nation, Métis, Inuit

16 Canadian Aboriginal Patients Number of Patients 2001/ / / / / / / / / / /12 Active Cancelled Preliminary Workup Number of Aboriginal Patient Searches / / / / / / / / /12 16

17 Aboriginal Patient Transplants ( ) Canadian Donors, 5 International Donors Germany, 2 Belgium, 1 United States, 24 Spain, 1 17

18 Products Used for Aboriginal Patients ( ) DLI 6% PBSC 23% Cord 53% Marrow 18% 18

19 Black and Multicultural Patient Searches Black Mixed Culture / / / / / /14 Number of Patients 2008/ / / / / /14 Black Multi Cultural

20 Canadian Black Patients Number of Patients 2001/ / / / / / / / / / /12 Active Cancelled Preliminary Workup

21 Why Cord Blood? Cord blood has distinct advantages over bone marrow or PBSCs: More lenient HLA matching requirements Units are available immediately Lower risk of graft-vs.-host disease (GvHD) Minimal risk to donor (mother and baby) More likely to find a match from someone of similar ethnic background. Today all cord blood units supplied by Canadian Blood Services for unrelated transplant are imported from international sources at significant cost. 21

22 National Public Cord Blood Bank Model Five collection sites and two manufacturing facilities for processing, storage and distribution. Please note: We will also be working on cord blood collection kits that can be sent to targeted areas outside of the cities listed below to reach Aboriginal communities, for example. Medical and Scientific Advisory Committee Searching, Matching Canadian Blood Services National Public Cord Blood Bank (inventory of approximately 18,000 units within 6 years*) OTTAWA Manufacturing Facility (Sept. 2013) EDMONTON Manufacturing Facility (mid-2014) CBS Support HLA Testing Transmissible Disease Testing Marketing & Recruitment CBS Research Ethics Committee (units unsuitable for transfusion) Canadian Transplant Programs OTTAWA Collection Sites (2) (Sept. 2013) EDMONTON Collection Site (mid-2014) Canadian Research Scientists International Registries BRAMPTON Collection Site (mid-2014) VANCOUVER Collection Site (mid-2014) 22

23 Cord Blood and Research Approximately 15% 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 cannot be used 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 CBS Research Ethics Board Canadian Stem Cell Network Canadian Blood and Marrow Transplant Group 23

24 Research Opt In for Collected Cord Blood Units that are not bankable Canadian Blood Services is developing a Cord Blood for Research Program to distribute the collected cord blood unit that is not bankable to research When the program is in place, the Permission to Collect consent form will be revised to include a research opt-in box a new research information pamphlet will be included in the maternal information kit Mothers will have the option to consent to donating their baby s cord blood to biomedical research if the unit is not bankable For further information on the research program, mothers are encouraged to: visit where summaries of the types of studies using cord blood will be listed.

25 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 National Systems Solution 25

26 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 26

27 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 27

28 Maternal Information Booklet 28

29 Who Can Donate? Healthy pregnant women, 18 years of age or older, can donate cord blood with their signed consent. A mother qualifies to donate her baby s cord blood if neither she nor her infant has any diseases or medical conditions that could be passed on to a patient who receives a cord blood stem cell transplant. Eligibility criteria have unique differences from whole blood. Mothers reaching 34 weeks or later who are not having a multiple pregnancy, may consider donating their baby s cord blood. A mother must deliver at one of our designated collection hospitals in order to donate her baby s cord blood to Canadian Blood Services national public cord blood bank. 29

30 Collection Three Collection Methods 1. Ex-utero: Fully supported by CBS NPCBB designated staff 2. In-utero (supported): All aspects of collection, labelling, packing/shipping by hospital staff CBS NPCBB 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 September, 2013 General Campus: Ex-utero Civic Campus: In-utero, CBS supported Remaining Collection Hospitals Edmonton, Vancouver, Brampton (GTA) Ex-utero 30

31 Manufacturing Stem Cell Manufacturing Facility: Peripheral Blood Apheresis / Bone Marrow: Processing, testing, storage, distribution FACT Accredited / GMP Guidelines Staffing: Charge Technologists and MLTs Manufacturing Equipment 31

32 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 32

33 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 HLA NIMA ABO QC samples storage 33

34 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 34

35 Searching and Matching Listed on OneMatch Registry Banked inventory of cord blood units Cords listed, searched and requested Searched both nationally and internationally Stem Cell National Systems Solution (IT system) Physicians / Clinical Transplant sites request banked cord blood unit Build on current OneMatch process 35

36 Distribution Requested Cord Blood for Transplant Manufacturing selects, releases, packs and ships Transport courier 36

37 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 37

38 What Transplant Physicians Want Transplant centres want to know about factors that influence the graft potency (i.e. volume, TNC, CD 34 + ) They want to know IDM are negative They want to be ensure the unit is matched They want to know the unit comes from an accredited bank They want to know their patient will not acquire a genetic or serious disease The Selection and Acquisition of Unrelated Cord Blood Grafts Dr. Juliet Barker et al, Blood 2011; 117:

39 Validation Phase First CBU at Civic Campus-July 12, 2012 First CBU at General Campus- October 24, 2012 Over 1000 cord blood units were collected for validation Training, validation of processes and equipment 39

40 Go- Live in Ottawa! September 30, 2013 Phase I of the National Public Cord Blood Bank went live in Ottawa with units now being collected and banked for transplant purposes Health Canada application sent on , in preparation for go-live. CBS received the official registration number for the distribution of cord blood stem cells for transplant on

41 Ethnicity Breakdown TOH General First Nations Inuit Métis Caucasian Jewish - Ashkenazi Jewish - Sephardic Black - African Black - Carribean Black - Other Arab Hispanic North Asian Chinese Northeast Asian Central Asian South Asian Filipino Southeast Asian Pacific Islander Multi-Ethnic Other None Listed TOH Civic

42 Phase II Go live Staff are being put in place in Brampton, Edmonton and Vancouver to begin working on our Phase II roll out to partner hospitals: -Brampton, ON William Osler Health System -Edmonton, AB To be announced shortly -Vancouver, BC To be announced shortly Progress is being made at our Edmonton Manufacturing Facility Renovations are nearly complete and most equipment received We are turning our attention to training and validation activities in preparation for Phase II Go-live in mid

43 Next Steps Recruitment and Collections Introduction and Awareness for all Health Care Professionals practising at the collection hospital Maternal Information Booklets delivered to clinics, offices Discussions with your mothers re: donating during validation and testing phase: Dec 2013-June 2014 Training, validation of processes and equipment to increase in proficiency GO Live Banking for transplantation by mid 2014.

44 Fundraising- For All Canadians Over $7.5 million raised to date As part of the "For All Canadians" fundraising campaign, Canadian Blood Services launched #Climb4Cord, a fundraising climb to the top of Africa's Mount Kilimanjaro in August 2013, to raise money, as well as to profile the need for a public cord blood bank in Canada over $350,000 raised 44

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