Cord Blood Bank Technology. E. Baudoux M. Duffy S. Querol L. Foeken. Survey Introduction

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1 Cord Blood Bank Technology E. Baudoux M. Duffy S. Querol L. Foeken Survey Introduction

2 Preliminary considerations

3 CB comparable to BM (Children) CB comparable to BM (Adults) Haplo identical transplants Heterogeneity of inventory Importance of HLA C CD34 recovery associated with banking practices FACT NetCord FACT NetCord Standards Standards st edition2 nd edition EU directive 2004/23/CE FACT NetCord Standards 3 rd edition US FDA licensure FACT NetCord FACT NetCord Standards Standards 4 th edition 5 th edition

4 Rationale for the survey Attempt of WMDA CBWG to: Understand the current trends Identify the main procedures in cord blood collection, processing, testing and storage Identify the main technical procedures currently used by public cord blood banks worldwide S. Querol Cord blood banking: current status Hematology 202

5 Intentions Catching the OPERATIONAL INVENTORY Make available to transplant centers, increasingly interested in o Characteristics of cord blood banks o Information about a specific cord blood unit Make available back to cord blood banks compare practices improve processes at their individual centers Potentially used for publication as a description of global public cord blood banking

6 Study design

7 Study design General data o Location, contact person Bank description and listing Cord Blood Units in Inventory Accreditations-licensescertifications Cord Blood Collection Conditioning and transport from Collection Centre to Cord Blood Bank Pre-processing evaluation Processing-Packaging Testing Storage Verification/Extended HLA Typing Confirmatory/verification typing Reservation/cancellation policies Release-Shipment Adverse Events Reporting

8 Preview of responses

9 Overall response Country CBBs Country CBBs Country CBBs Country CBBs BELGIUM 5 Finland Japan Sweden Brazil 3 FRANCE 2 Russia Switzerland 2 Canada 2 Germany 3 Singapore Thailand China Greece Slovakia Turkey CYPRUS Israel 2 Slovenia UK 2 Czech Republic Italy 5 SPAIN 3 USA 5 24 Countries 57 responding banks

10 Inventory of responders by country UK, 23,564 China, 20,959 Germany, 3,29 SPAIN, 42,63 BELGIUM, 9,223 FRANCE, 3,926 Italy, Singapore, 0,894 0,908 Israel, 0,209 Canada Japan Russia USA, 22,950 Others Brazil Sweden Czech Republic Finland Cyprus Slovakia Greece Switzerland Thailand Slovenia Turkey TOTAL SURVEYED INVENTORY:

11 Creation of banks Implementation of current process Bank created Started with current process

12 Plan for storage in , , ,000 5, , ,000 0 NR 00 and below above 000 0

13 Plan for storage in Expected growth and inventory size 8 8 No Growth 0-50/ / /000 Number of banks / /000 Over 500/ up to over Size of existing inventory

14 Fulfilling evolving requirements TNC threshold Number of Banks Special policy for minorities Under and above NR Pre-Processing TNC threshold (x0e7)

15 Fulfilling evolving requirements HLA 80% 70% 60% LR IR HR 50% 40% 30% 20% N=42 N=42 N=35 N=42 N=5 N=7 0% 0% HLA A HLA B HLA C HLA DRB HLA DQB HLA DPB

16 TNC Counts of the CBUs listed in BMDW TNC count CBUs (%) > not available

17 Total nucleated cells in surveyed inventory > TNC (x0e7) Below 50 0% 5% 0% 5% 20% 25% 30% 35%

18 Listed in BMDW BMDW No 27% Yes 73%

19 Affiliation to donor registry No % Yes 89%

20 Accreditations State license Both (FATC+AABB) FACT Only AABB only None 3 banks 25 banks 8 banks 7 banks Yes No In process NR 0 0 FACT and/or AABB Audited by registry Competent authority ISO

21 Processing methods Currently Never Done previously, not anymore Liquid phase Vapour phase LPh VPh LPh VPh LPh VPh LPh VPh LPh VPh VOLRED MANUAL VOLRED AUTO Plasmaredonly VOLRED MANUAL VOLRED AUTO Plasmaredonly WITH SEGMENTS NO SEGMENT

22 Type of units in inventory % 6% 38% Plasma and RBC RED Manual Plasma and RBC RED Automatic RBC reduction only No VR 55%

23 Plan Preview Monaco CBWG discussion Istambul (WMDA spring meeting) Data compilation, questions to responders (spring and summer) Online ressource for TCs and banks Online catalog of units in pictures Summary and paper draft (WMDA fall meeting) Publication (?? Late 205)

24 REFERENCES Raiola et al. Unmanipulated Haploidentical Transplants Compared with other Alternative Donors and Matched Sibling Grafts Biol Blood Marrow Transplant 20 (204) Querol Cord blood banking: current status Hematology. 04/202; 7 Suppl :S85-8 Purtill et al. Dominant unit CD34 cell dose predicts engraftment after double-unit cord blood transplantation and is influenced by bank practice Blood, Vol 24 (204)

25 Responders Thanks Sergio Querol Merry Duffy Lydia Foeken Rachel Glissmann Katie Paulson Monique Joris Amy Andrews Sue Armitage Anne Arvola Janete Baldissera Etienne Baudoux Paola Bergamaschi Dazey Bernard Flavio Braga Theofanis Chatzistamatiou Dominique De Bleser Cécile De Bruyn Timothy Devos Nicholas Dibdin Judy DiSanti Suanne Dorr Susana G Gomez Ronit Goldman-Levi Jose Hernandez Renate Hintermeier-Knabe Donald Hudspeth Susie Joron Vincent Kindler Gesine Kögler Metka Krasna Pawinee Kupatawintu Marie Kurikova Dominique Latinne IOULIETA LIATSOU Juan Lieu Alfredo Mendrone Junior Zbigniew Mrowiec Kerstin Nessel Azita Nourani Mario Pagano Phil Paul Ovchinnikov Pavel MIGUEL ANGEL PEREZ Laura Ponce Fabienne POUTHIER Arun Prasath SERGIO QUEROL Shimon Rabinowitz Donna Regan Alex Ross Maria Sanciova Maria Screnci Yesi Sevilla Dorothy Sung Minoko Takanashi Anna Tamburini Carol Taylor Dimitrios Tsakiris SERENA URBANI Berit Waldner Stephanie Warnell Xiaofei Wei Pinar Yurdakul

International NetCord Foundation Executive Committee Conference Call Minutes September 10, 2014

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