An Introduction to Canada s National Public Cord Blood Bank

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1 An Introduction to Canada s 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 Lymphoma 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 Increasing need for UCB With declining fertility rates in recent decades, fewer patients will have HLA-matched siblings There will be an increasing reliance on alternative sources of cells such as cord blood or unrelated donors Cord blood banking may represent an ideal strategy to embrace the evolving ethnic diversity in a given jurisdiction. Especially relevant given diverse immigration patterns over recent decades in Canada. HLA-compatibility in cord blood transplantation is less stringent than with bone marrow or peripheral blood progenitor cells

8 Reducing fertility rates = fewer matched related sibling donors Allan et al, BBMT 2009 Slide kindly shared by Dr. David Allan, Canadian Blood Services

9 Table. Calculating the chance of identifying an HLA-matched sibling donor depending on the year of birth of the donor. Donor/patient birth year Average birth rate (actual) Sibling Rate (calculated) Chance of 1 HLA-matched sibling donor (calculated)* % % % % % % % % % % % Allan et al, BBMT 2009 Slide kindly shared by Dr. David Allan, Canadian Blood Services

10 OneMatch Fast Facts May 2014 Searchable donors: 342,224 Canadian Transplant Centres: 12 Canadian Collection Centres: 8 International Registries: 73 Over 24,069,577 registrants worldwide International Cord Blood Banks: 47 Over 607,895 umbilical cord blood units Francis, OneMatch Registrant 10

11 11 OneMatch Registrants: May 2014 N=342,224

12 12 Ethnic composition of OneMatch database

13 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. 13

14 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! July 7, 2014 Go-live in Brampton (Greater Toronto Area) End of 2014 Edmonton, Vancouver 14

15 Number of Patients Canadian Patient Searches- The demand and need continues to increase / / / / / / / / /2013 Total 15

16 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 16

17 Number of Cord Units Procured Cord Units Selected for Canadian Patients / / / / / / / /2013 Fiscal Year International Cords Hema-Quebec Cords 17

18 Number of HPC Cord shipped Number of Cord Blood Units provided for Unrelated Transplantation (Data courtesy of WMDA) Number of cord blood units provided for unrelated transplantation 4,500 4, ,150 3,500 3, ,093 2,500 2,000 1,500 1, Year No information provided Units provided for adults Units provided for children 18

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

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

21 Canadian Aboriginal Patients Number of Patients 2001/ / / / / / / / / / /12 Active Cancelled Preliminary Workup Number of Aboriginal Patient Searches / / / / / / / / /12 21

22 Aboriginal Patient Transplants ( ) Canadian Donors, 5 International Donors Germany, 2 Belgium, 1 United States, 24 Spain, 1 22

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

24 Chinese and South Asian Patient Searches Chinese South Asian / / / / / /14 Number of Patients 2008/ / / / / /14 Chinese South Asian

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

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

27 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. 27

28 National Public Cord Blood Bank Model Five collection sites and two manufacturing facilities for processing, storage and distribution. Canadian Blood Services Medical and Scientific Advisory Committee Searching, Matching OTTAWA Manufacturing Facility (Sept. 2013) EDMONTON Manufacturing Facility (2014) CBS Support HLA Testing Transmissible Disease Testing CBS Research Ethics Committee (units unsuitable for transfusion) Marketing & Recruitment Canadian Transplant Programs OTTAWA Collection Sites (2) (Sept. 2013) EDMONTON Collection Site (2014) Canadian Research Scientists International Registries BRAMPTON Collection Site (2014) VANCOUVER Collection Site (2014) 28

29 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. Mother s in Ottawa will have the option to donate their baby s cord for research in Canada if it cannot be used for transplantation. 29

30 Cord Blood for Research Program The Cord Blood for Research Program mission is to facilitate research that promotes advances in the fields of transfusion, cellular therapies and transplantation medicine in Canada. Canadian Blood Services Cord Blood for Research Program distributes to approved research projects, and with the mother s consent, cord blood products collected at the Ottawa Hospital that do not meet the criteria for storage in Canadian Blood Services National Public Cord Blood Bank. The program began on Research projects are being approved and cord blood units are being distributed for research 30

31 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 31

32 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 32

33 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 33

34 Maternal Information Booklet 34

35 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. 35

36 Collection Two 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 The Ottawa Hospital September, 2013 General Campus: Ex-utero Civic Campus: In-utero, CBS supported Remaining Collection Hospitals, 2014 Edmonton, Vancouver, Brampton (Greater Toronto Area): Ex-utero 36 36

37 Collection Five Collection Sites: TNC cutoff 1.5 X 10 9 Caucasian TNC cutoff 1.3 X 10 9 Ethnically diverse 37

38 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 38

39 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 39

40 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 40

41 The IPA/NIMA effect Mother IMA/NIMA Father IPA/NIPA NIMA = non inherited maternal antigens NIPA IMA IPA = non inherited paternal antigens = inherited maternal antigens = inherited paternal antigens The mother develops B and T cell immunity against the IPA of the fetus, which is controlled by T reg. PNAS 2012 Likewise, the foetus develops immunity and Tregs against the NIMA. CTL s and Tregs identified in foetus, cord blood and adults. Foetus IMA/IPA Immunity and regulation can be lifelong in both mother and child. PNAS 2009 Slides courtesy of Jon J. van Rood, Leiden University Medical Center and Europdonor Foundation

42 Identification of an acceptable mismatch with the help of NIMA van Rood et al. Pnas: 2009, 106, pp Patient cord blood A1, A2 - B7, B44 A1, A3 - B7, B44 mother of CB A1, A2 - B7, B8 NIMA=A2 and B8 Combining the NIMA A2 and/or B8 with the CB phenotype can create e.g. the Virtual CB phenotype: A1, A2 / B7, B44 and 5 other Virtual Phenotypes (VP) if there is 1 substitution, 12 when there are 2 and 8 when there are 3. HLA typing of the mother can create 26 up to different VPs!! Slides courtesy of Jon J. van Rood, Leiden University Medical Center and Europdonor Foundation

43 Transplant-Related Mortality (Patients 10 Years Old) 80 % with TRM (Cum. Incid.) MM, No NIMA Match Reference N= MM, 1NIMA Match N= 31 1 MM, No NIMA Match Reference N=131 1 MM, 1NIMA Match N= Years Post-Transplant 0 Mismatch 4/22 RR=0.3 P = MM, 1 NIMA 20/41 RR=0.6, P= PNAS (47) p10952

44 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 44

45 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 45

46 Distribution Requested Cord Blood for Transplant Manufacturing selects, releases, packs and ships Transport courier 46

47 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 47

48 What Transplant Physicians Want Want to know about factors that influence the graft potency (i.e. volume, TNC, CD 34 + ) Want to know IDM are negative Want to be ensure the unit is matched Want to know the unit comes from an accredited bank 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:

49 Operations Update Ottawa & Brampton

50 Ottawa Monthly Collections by Site TOH - General TOH - Civic October* November December January February March April May June July August ** *Note that this figure includes September 30 th. **Note that this is an ongoing month. Figure includes Aug

51 Volume (ml) Ottawa Average CBU Volume (ml) by Month and by Site 140 TOH - General TOH - Civic October* November December January February March April May June July August** *Note that this figure includes September 30 th. **Note that this is an ongoing month. Figure includes Aug

52 Ottawa Cumulative Average of Pre-Production TNC 1.3 Caucasian 1.27 Non-Caucasian TOH - General TOH - Civic Both 52

53 Brampton Average of Pre-Production TNC Caucasian Non-Caucasian 53

54 Ottawa Ethnicity of All Cord Blood Units Collected 60% 50% 40% 30% 20% 10% 0% 1849 units collected between to % 18% Caucasian Multi-Ethnic 15% None Listed 8% 5% 4% 0.38% Other Asian Black Aboriginal Caucasian 49% Multi-Ethnic 18% None Listed 15% Other 8% Asian 5% Black 4% Aboriginal 0.38% Arab 69% Hispanic 15% Jewish-Ashkenazi 3% Jewish-Sephradic 1% Pacific Islander 0% Other 12% Central Asian 11% Chinese 24% Filipino 10% North Asian 1% Northeast Asian 6% South Asian 28% Southeast Asian 20% African 61% Caribbean 28% Other 11% First Nations 43% Inuit 43% Métis 14% 54

55 Brampton Ethnicity of All Cord Blood Units Collected 60% 50% 40% 30% 20% 10% 0% 163 units collected between to % 23% 12% 10% 4% 3% 0% Asian Caucasian Multi-Ethnic Black Other None Listed Aboriginal Asian 48% Caucasian 23% Multi-Ethnic 12% Black 10% Other 4% None Listed 3% Aboriginal 0% Central Asian 0% Chinese 1% Filipino 4% North Asian 5% Northeast Asian 6% South Asian 71% Southeast Asian 13% African 25% Caribbean 63% Other 13% Arab 17% Hispanic 50% Jewish-Ashkenazi 0% Jewish-Sephradic 0% Pacific Islander 0% Other 33% First Nations 0% Inuit 0% Métis 0% 55

56 Phase II Project Update Edmonton, Vancouver

57 Phase II Update PV started on , as scheduled 12 bankable units required Proposed Go-live for Edmonton/Vancouver Collections and Edmonton Manufacturing is on track for December, 2014.

58 Phase II Vancouver Collections BC Women's Hospital and Health Centre First collection for validation/training purposes took place on February 18,

59 Phase II Edmonton Collections Lois Hole Hospital for Women First collection for validation/training purposes took place on February 24,

60 Phase II Edmonton Manufacturing Vestibule/Entrance 60

61 Phase II Edmonton Manufacturing Processing 61

62 Phase II Edmonton Manufacturing Testing 62

63 Phase II Edmonton Manufacturing Cryopreservation 63

64 Fundraising- For All Canadians Over $9.19 million raised to date 64

65 65

66 66

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