Public Umbilical Cord Blood Banking at Canadian Blood Services. David Allan, MD Medical Director, National Public Cord Blood Bank 6 May 2015

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1 Public Umbilical Cord Blood Banking at Canadian Blood Services David Allan, MD Medical Director, National Public Cord Blood Bank 6 May 2015

2 Overview Quick review of stem cell transplant activity Cord blood banking: update and medical perspective OneMatch registry: update and medical perspective Opportunities and challenges ahead

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4 Canadian Stem Cell Demand Hematopoietic Stem Cell Transplant Volume, by Region, by Donor Type, Canada, 2013 Autolog Alloge Cord Region Total ous neic Blood TOTAL CANADA 1,899 1, NON-QUEBEC 1, ALBERTA BRITISH COLUMBIA MANITOBA NEW BRUNSWICK NEWFOUNDLAND AND LABRADOR NOVA SCOTIA ONTARIO PEI SASKATCHEWAN TERRITORIES QUEBEC

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6 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 umbilical cord blood, URD and haplo 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

7 Reducing fertility rates = fewer matched related sibling donors Allan et al, BBMT 2009

8 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

9 Canadian Stem Cell Supply 66% of Canadian patients are receiving optimum 10/10 unrelated donor Canadian donors are chosen when available, especially if young and male Lack of high resolution typing or missing allele typing are roadblocks to selection International donor used to reach better match level Use of cord, even in pediatrics, associated with lack of available adult donor Canadian donors for International Patients similar match results 2013 HLA Match Distribution Unrelated Donor Transplants 2013 HLA Match Distribution Cord Transplants Level of HLA Match % Transplants 10/10 71% 9/10 26% 8/10 and below 1% 8/8 2% Level of HLA Match % Transplants 6/6 5% 5/6 46% 4/6 68% 9

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11 International Registries & Cord Blood Banks Top 10 Adult Donor Registries*: 1.U.S. NMDP - 7,653,680 2.Germany ZKRD - 5,678,790 3.Brazil 3,394,812 4.Israel 730,588 5.China 686,841 6.Japan 446,295 7.UK Anthony Nolan 545,540 8.Poland DKMS 541,103 9.Portugal 351, Canada OneMatch 348,407 ~ Top 10 ~ 85% of 24.2 million adult donors worldwide *BMDW October 2014 Top 10 Cord Blood Banks*: 1. U.S. NMDP 135, U.S. New York 60, Spain 59, Taipei 35, France 33, Italy 32, Australia - 27, Korea Konos 25, U.K. BBMR 20, U.S. StemCyte 20,642 ~ Top 10 ~ 75% of 618K CBUs worldwide 11

12 National Public Cord Blood Bank Actively collecting in Ottawa (2 sites) and Brampton Nearing completion of validation phase in Edmonton and Vancouver: Go-live date is imminent Manufacturing sites in Ottawa (live) and Edmonton (PV) Listed on BMDW in 2014 expect to have 500 cords listed by early 2015 Expecting first product request in 2015

13 An update Collected 1000 units in Ottawa in 2013/14 So far in 2014/15, 1300 units collected Overall, 50% of units collected from non- Caucasians Overall, 23% bankable rate Cords for Research Program launched in 2014 and non-bankable units are directed to biomedical research

14 Striving for Quality Banked units have a high cell content: 1.5 x 10 9 (1.25 x 10 9 for non-caucasian ethnicity) More than 80% of selected cords are in this cell content range Among 175,000 units banked in the US, only are in this range of cell content [NMDP] We are capturing high ethnic diversity, reflecting the needs of Canadian patients HLA diversity complements OneMatch Registry

15 The Selection and Acquisition of Unrelated Cord Blood Grafts Dr. Juliet Barker et al, Blood 2011; 117: Transplant centres typically want to know about factors that influence the potency of the graft Want to know IDM s 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 15

16 Factors that Influence the Potency of the Graft Volume TNC CD34 CFUs ALDH SRC Combinations of factors 16

17 Combining factors in a scoring system Recent reports have started to examine the role of combining several factors to optimize selection of cord blood units for transplantation. In a recent paper by Page et al, the hazard ratios for precryopreservation and post-cryopreservation graft viabilities for TNC, CD34+ cells, CFUs, MNCs and volume were collected were calculated in terms of their correlation with neutrophil engraftment. The magnitude of the hazard ratios was then used to develop a scoring system that is intriguing. More study is required on the development of scoring systems for selecting cord blood units before a recommendation can be made. Page KM, et al. Transfusion, 2012;52:

18 A systematic review of ethnicity and cord blood collections Ref Ethnicities Studied Storage rate Volume TNC CD34 CFU Cntry Private or Public [10] Caucasian (276) vs AA (276) AA AA USA Public [23] AA (200), Caucasian (1209), Asian (16), Hispanic (59), Other (154) [22] White (3631), AA (1253), Asian (987), Hispanic (1841), Other (1018) [18] Caucasian (5015), AA (1254), Hispanic (940), Asian (313), Native American (78), Other (235) AA AA * USA Public AA, Asian [20] Caucasian (810) vs non-c (108) non-c *** AA AA AA USA Public ** AA USA Public [24] Caucasian (3103), AA (1064), Hispanic (680) AA USA Public [19] Caucasian, AA, Asian, Hispanic, Other Non-C USA Public [27] Caucasian (39), non-caucasian (30) Non-C UK Public [21] Caucasian (3473), AA (2582), Hispanic (2404), Asian (356), other (89) [25] Asian (1949), AA (22), Hispanic (117), Caucasian (1888), Other (39) [26] Taiwan: Hoklo (1367), Hakka (163), Mainlander (149) AA, Asian non-c *** USA USA Public Public AA Canada Private Taiwan Public (unpublished)

19 HLA-matching AABB or NetCORD/FACT accreditation status of bank Recipient weight Centre's experience Available segment for post-thaw testing on unit Rapidity of shipping Cost of CBU Available health status of cord blood donor Patient age Remoteness of recipient to transplant centre Mean Rating (scale of 1 10) Recent Survey of CBMTG members (n=40) regarding barriers to greater use of cord blood transplantation in adult patients. [Chan J et al, BMT 2013.] Chan et al, BMT 2013

20 Understanding the Canadian Perspective Survey results are consistent with recently published reviews of factors influencing outcomes in UCBT. Based on our survey, public cord blood banking efforts in Canada should focus on: 1) ensuring broad HLA diversity, 2) pursue and maintain the highest levels of accreditation, and 3) endeavour to achieve an inventory of units with high cell counts to offset concerns related to large adults. Some factors that are perceived to be less important within the Canadian context are in contrast to recent literature. ie, distance from the transplant centre has been reported to negatively influence transplant outcomes including one study performed in Canada. Having a diverse inventory with optimal units of high quality will allow adult transplant centers to develop greater expertise and experience in cord blood transplantation. Abou-Nassar KE, et al. BBMT, 2012; 18: Paulson K, et al. BMT, 2010; 45:

21 Ottawa Ethnicity of All Cord Blood Units Collected Caucasian 49% Multi-Ethnic 18% None Listed 15% Other 8% Asian 5% Black 5% Aboriginal 0.41% Arab 68% Hispanic 16% Jewish-Ashkenazi 2% Jewish-Sephradic 1% Pacific Islander 0% Other 13% Central Asian 10% Chinese 25% Filipino 10% North Asian 1% Northeast Asian 6% South Asian 28% Southeast Asian 19% African 61% Caribbean 29% Other 9% First Nations 50% Inuit 38% Métis 13% 21

22 Brampton Ethnicity of All Cord Blood Units Collected Asian 47% Caucasian 26% Multi-Ethnic 11% Black 9% Other 4% None Listed 3% Aboriginal 0% Central Asian 0% Chinese 1% Filipino 8% North Asian 7% Northeast Asian 5% South Asian 66% Southeast Asian 12% African 26% Caribbean 53% Other 21% Arab 25% Hispanic 50% Jewish-Ashkenazi 0% Jewish-Sephradic 0% Pacific Islander 0% Other 25% First Nations 0% Inuit 0% Métis 0% 22

23 Ontario Microbiology 0.83% contamination rate Five units contaminated out of 606 qualifying units 5 from TOH Civic Campus, 0 from TOH General Campus, 0 from Brampton Civic Hospital 23

24 Total Number of NCRs by Source Ottawa Collections Brampton Collections* Manufacturing Other Total * Note Brampton Go-Live date:

25 Challenges Growth projection is below what was initially proposed, largely due to change in cell cutoffs Allows us to bank units with higher quality Use of cord blood has levelled internationally Greater use of haploidentical donors, cost are issues Economic viability of cord blood banking worldwide Cost of international cord units is decreasing May drive greater demand May impact self-sufficiency

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27 and opportunities Increasing demand for transplant in some areas hemoglobinopathies Novel uses of cord blood are increasing Regenerative therapy Immune modulation Technologies such as stem cell expansion with cord blood are emerging on the market: team at HMR (CIHR trial, Science 2014) Novartis has a product (NiCord) Systematic review of strategies ongoing (CBS CTRUoO) Microtransplantation for elderly patients with AML could be well suited to cord

28 Transplantation of umbilical cord bloodderived cells for novel indications in regenerative therapy or immune modulation: a scoping review of clinical studies Marco A. J. Iafolla, Jason Tay, David S. Allan Biology of Blood Marrow Transplant, 2014

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30 Disease Categories Published (pts) Neurological 9 (156) 23 Spinal cord injury 2 (2) 3 Traumatic brain injury 1 (6) 4 Stroke 2 (11) 3 Neurodegenerative disorders 2 (115) 2 Cerebral Palsy, Neonatal hypoxic-ischemic encephalopathy & Global Developmental Delay 2 (22) 9 Autism 0 1 Preterm neonates 0 1 Diabetes mellitus 2 (30) 8 Type 1 diabetes mellitus 2 (30) 7 Type 2 diabetes 0 1 Cardiac and Vascular 3 (12) 3 Thromboangiitis obliterans 2 (11) 0 Critical limb ischemia 0 1 Hypoplastic left heart syndrome 0 1 Idiopathic dilated cardiomyopathy 1 (1) 1 On-going Studies (pts)

31 Disease Categories Published (pts) Hepatic/Gastrointestinal 2 (99) 9 Liver cirrhosis 1 (30) 7 Viral hepatitis 1 (69) 1 Ulcerative colitis 0 1 Dermatological 1 (2) 2 Skin wound, burn 1 (2) 1 Epidermolysis bullosa 0 1 Other 3 (18) 2 Rheumatoid arthritis 0 1 Systemic lupus erythematosus 1 (16) 1 Duchenne Muscular Dystrophy 2 (2) 0 Total count 20 (317) 47 On-going Studies (pts)

32 Table 4: Geographic regions treated with UCB stem cells Geographic Region Published (pts) On-going studies (pts) China 8 (261) 26 USA 4 (32) 9 Korea 4 (13) 6 European Union + UK 2 (3) 1 Thailand 1 (2) 0 Russia 1 (6) 0 Egypt 0 1 Mexico 0 1 Singapore 0 1 South America 0 1 Australia 0 1

33 Cell type administered TNCs, MNCs, or CD34- selected cells Published (pts) On-going studies (pts) 10 (227) 19 Intravenous (or not stated) 7(104) 15 intrathecal, subcutaneous, or intramuscular 3 (123) 4 MSC or cultured adherent cells 8 (88) 24 Intravenous (or not stated) 5 (82) 24 Intrathecal or intramuscular 3 (6) 0 Combined CD34-selected cells and MSCs 2 (2) 4 Intravenous (or not stated) 1 (1) 4 intrathecal 1 (1) 0 Cell Source 20 (317) 47 Allogeneic cells 18 (300) 34 Autologous cells 2 (17) 13

34 Unrelated donor registry Ideal registrant: under 35 and male Represents most common choice of TCs (WMDA) Resource utlization is optimized Want donors with retention Growth plans: 300,000 registrants now HLA diversity Efforts to recruit rare HLA types not clearly the way to go although greater diversity on registry, number of Canadian patients transplanted with Canadian donors is stable Donor retention An important issue for reputation and for patient benefit

35 Challenges and Opportunties How big should the registry be? What is the ideal ethnic mix? Should we remove donors from the list who are no longer motivated to donate? How can we increase our role in transplantation in Canada Best practices Standardization and resources for matched donors Data sharing with groups such as CBMTG to optimize patient outcomes

36 Wrap-Up Role of the MD at CBS? Monitor transplant clinical care trends Liase with transplanters (end-user) Monitor emerging threats to donors, patients, Embrace new directions at the right time regarding new practices that impact patient outcomes

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