Establishing a Cord Blood Bank in a Regional Blood Center. Kristy Unold, MT(ASCP)SBB, CQA(ASQ) Amy Lambert, MM, BSChE

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1 Establishing a Cord Blood Bank in a Regional Blood Center Kristy Unold, MT(ASCP)SBB, CQA(ASQ) Amy Lambert, MM, BSChE

2 Our Regional Blood Center *260,000 blood components collected in calendar year 2011

3 Mission Statement: To provide hematopoietic stem cells from umbilical cord blood that meet or exceed industry standards for transplantation worldwide. Vision Statement: We aspire to be a nationally and internationally recognized public cord blood bank with a reputation for excellence in the field of cellular therapy. Giving Hope Around the World

4 Cord Blood Cord blood, also known as placental blood, is the blood that flows in the umbilical cord and the placenta of the developing fetus in the womb. After the birth of the baby there is excess cord blood left in the placenta This blood is a rich source of stem cells, the cells that create all of the blood cells of the body Through research we have developed methods for processing and storing this excess cord blood so the cells can be used for treating patients who need bone marrow transplants.

5 Stem Cells Why So Important? Stem cells generate various cell lines Sources of stem cells: bone marrow, peripheral blood (after stimulation), and umbilical cord blood These sources can generate hematopoietic and mesenchymal cell lines Committed cells may generate other tissue specific cell lines

6 Cord Blood Source for Hematopoietic Stem Cells

7 Annual Transplantation Rates in the United States 18,000 patients in need of stem cell therapy 5,500 have a sibling donor (30%) 12,500 searches for unrelated donors 4,000 adult stem cell transplants performed (20%) 1,000 cord blood transplants performed (5%) 9,000 patients do not receive a transplant (45%) Data from CIBMTR and NMDP

8 Likelihood of a Match The Be The Match Registry provides access to 9 million potential donors and more than 185,000 cord blood units. o o LifeCord s inventory currently account for approximately 2.2% and growing Through partnerships with international registries, the NMDP provides additional access to more than 7.5 million donors and 365,000 cord blood units. Data acquired from NMDP

9 Number of donations Trends in Transplantation 18,000 16,000 14,000 12,000 10,000 8,000 Stem Cell Products provided for unrelated transplantation Bone Marrow 3,445 3,221 PBSC 8,162 7,260 Cord Blood Units 3,749 3,522 24% from CBU 6,000 4,000 2,000 0 Data acquired from NMDP Year BM donations PBSC donations Cord Blood Units Provided

10 Number of cord blood units CBU Transplantation Worldwide View 139 Cord Blood Banks Number of CBUs provided for unrelated transplantation 4,000 3,500 3,000 2, CBUs shipped 3,556 3,792 2,000 1,500 1, Units provided for children Units Year provided for adults No information provided Data acquired from NMDP

11 National Marrow Donor Program Single vs. Multi Cord Transplants Calendar Years ,200 1, Single Cord Multi Cord Data acquired from NMDP

12 2010 Trends In CBU Transplants Data acquired from NMDP

13 Transplant Trends 15% Increase in AA transplants 38% Increase in Asian transplants 22% Increase in Marrow transplants Only 4% Increase in PBSC increase Largely due to the NMDP study findings and discussion before publication Data acquired from NMDP

14 Benefits of UCB vs. Adult Stem Cells UBC cells are at the intermediate point between embryonic/fetal and adult life Longer telomeres per chromosome which leads to high cell proliferation Reduced risk of viral infections (CMV and Epstein Barr virus) Reduced incidence of GVHD during allogeneic transplantations Better tolerance for (HLA) mismatches Valuable source in terms of access and supply

15 How Began In 1997, three entities came together: Research interest -- University of Florida transplant group Existing cellular therapy processing laboratory for bone marrow/pbsc collections at Shands at UF Three-state blood collection system LifeSouth -- serving >100 hospitals in multiple cities

16 How Began (cont.) Common ground for all parties: Interest in cellular therapy/cord blood research No other public cord blood bank in any of the 3 states Demographically desirable because of the ethnic diversity of the population served by the blood center

17 FACT accredited Public Cord Blood bank Founded to make allogeneic transplants possible Adheres to the highest standards of quality and safety Ensures the safety of each donation for both mom and baby Protects the confidentiality of personal and family medical history

18 What All Parents Should Know Cord blood allows more patients access to transplantation options More Potential for diversity Parents have a choice between Private and Public Cord Blood Banks There is no cost for donating cord blood to a public cord blood bank, such as LifeCord. LifeCord incurs the cost of collecting, testing, processing and storing the cord blood

19 The LifeCord Program

20 Cord Blood Collection Sites

21 LifeCord s Growth Potential = Potential = Existing

22 Reasons for Opening Collection Sites To recruit local ethnicities To enhance a CB inventory To enhance the status of a medical center or hospital by offering public CBB To respond to local moral demand To create a business opportunity

23 Operational Challenges Obtaining approval for Investigational New Drug application from the U.S. FDA Obtaining Institutional Review Board approval at each collection site (hospital) Setting up the collection model 1. LifeSouth staff provide all aspects (in utero or ex utero collection) 2. LifeSouth staff train OB and L&D nurses to perform actual collection, then completing the remaining activities 3. Using mail-in sample collection

24 Collection Site Challenges Obtaining labor and delivery records postpartum Establishing storage sites for keeping kits at hospitals and for holding cord blood units prior to transport to LifeSouth Transporting cord blood units from collection sites to LifeSouth Obtaining consent from mothers

25 Collection Site Challenges (cont.) Receiving samples for testing mothers for infectious diseases Harmonizing activities between facilities Obtaining all documents in a timely manner 48 hours post-collection to complete cryopreservation; 90 days to list with NMDP

26 Historical Operational Challenges Schedules collections = 24/7; processing 8/5+; testing 24/7; storage 8/5; distribution 8/5 Information system support LifeCord = uses LifeSouth s donor IT system and NMDP s CordLink Manual records for non-infectious disease testing Shands = manual records Contract labs = fax Hospitals = manual records; 1 site allows direct access to EMR

27 Historical Operational Challenges Storage Quarantine (up to 60 days) at Shands Long-term at LifeCord Distribution Physical packing; record generation at LifeCord Final sign-off at University of Florida

28 Historical Workload Distribution University of Florida Shands at UF LifeSouth Community Blood Centers, Inc. Medical direction/oversight Technical expertise in cell processing; microbiology and HLA Recruitment, collection, transportation, infectious disease testing, initial evaluation, long-term storage, records management, distribution

29 WHAT CHANGED?

30 Cord Blood to be Licensed! Cord Blood Stem Cell Act of 2005 FDA New guidance - submission of BLA for licensure October 20, 2011 Sept. 2010, Congress extends funds to be distributed through HRSA for 5 more years Congress wants 150,000 banked high quality CBUs in the NCBI

31 Stem Cell Therapeutic & Research Act of Structure & Funding DHHS HRSA Div. Of Transplantation National Cord Blood Inventory National Cord Blood Coordinating Center Bone Marrow Coordinating Center Stem Cell Transplant Outcomes Database Office of Patient Advocacy Cord Blood Banks

32 Pharmaceutical Regulations LifeCord met with FDA staff at pre-bla meeting in November 2010 FDA was enforcing stringent a manufacturing model for cord blood

33 New Model Three-part shared process Medical Direction by UF faculty Processing (manual) Testing IRB oversight/research consent Consolidated model LifeSouth Medical Director Automated processing in new facility with clean room and dedicated laboratory New contracted labs: HLA, infectious diseases Clinical consent from moms

34 Design of a Cord Blood Processing Laboratory

35 Design Goal Single Shift Production capacity 5,000+ CBU/year Storage Capacity of over 20,000 CBU plus expansion Distribution Capacity??? CBU/year Meet or Exceed BLA Requirements

36 Basis of Design Receiving/Accessioning Processing/Cryopreservation Freezing/Storage Quality Control Labs (CBC, Bacteriology, CFU) Area for sample send outs (HLA, HgB, etc.) Flow Lab (CD34 and Viability) move from IRL? Data Entry/Document Storage Distribution & Shipping Supply Storage, Admin Offices

37 Controlled Suite/Processing Area FDA GUIDANCE DOCUMENT: This section should contain a description of segregation and containment procedures for areas, manufacturing operations, personnel, equipment and waste materials designed to prevent contamination of products.

38 Environment FDA GUIDANCE DOCUMENT: A description of the environmental quality of each room and each aseptic processing area A brief description of any environmental monitoring program, including monitoring for airborne viable and nonviable particles, surface sampling, frequency of the monitoring, and alert and action levels that have been established for each area.

39 Layout CLEAN ROOM WORK ROOM LONG-TERM STORAGE

40

41

42

43 New Automated Processing and Testing Instruments/Purpose Sepax 2 + CoolMix Processing cord blood units and adding DMSO Bioarchive Controlled rate freeze and storage Stem Vision CB Cell culture/counting BacTAlert Microbial culturing Sysmex Blood cell counting FACSCaliber CD34 counting/viability

44 Validations Collection sites and collectors Materials (cleaning supplies) Chemicals used in processing Equipment/Instruments IQ/OQ/PQ Comparability (e.g., bacterial testing) Methods (environmental monitoring, sterility, stability) SOPs Processes Shipping/Distribution/Storage Vendors/supplies Training CBU Testing

45 Thaw / Wash

46 Fixed Costs for Cord Blood Banking Facility Medical Director Laboratory Director Quality Manager Cellular Therapy Manager Processing Technologists and CT Staff Administrative Staff Insurance Storage Informatics

47 Variable Costs for Cord Blood Banking Collection bags Processing kits Collection and Shipping Cryopreservation Media Sterility testing Media EM Media IDM, HLA, Hemoglobinopathy Testing

48 cgmp Banking Costs per Unit (6,000 Collections per year and CBUs Banked) Recruiting costs (supplies and labor) $ 268 Processing costs (cgmp) $1,524 Overhead $ 505 Maintenance $ 25 Total $2,322

49 The Business Side of Cord Blood Cord blood banking is a challenging business. Return on investment is long term (10 years). Highly regulated (FDA cgmp requirements). World wide market competition. Bank must develop a reputation (i.e. marketing) Market is susceptible to new technologies and may be price sensitive.

50 Status BLA originally submitted 11/03/11; withdrew 12/15/11 based on initial FDA review resubmission in May 17, 2012 Substantial recent effort invested in implementing quality practices throughout organization; hiring new staff; revising SOPs; finalizing validations Expecting FDA on site inspection within next few months

51 LifeCord s Progress to Date >20,000 collections 4,483 cords listed for public use 95 cords provided for transplantation >1,000 cords not meeting banking acceptance criteria have been released for research under 13 IRBapproved protocols

52

53 5000 Cord Inventory at Year End by Race Unk Multi HIS CAU API AFA

54 Current Stem Cell Research

55 Induced pluripotent stem cells from somatic cells hold great promise for modeling human diseases Donated cells not ESCs Able to reprogram cells Expansion in cultures Generate patient-specific ipscs Heart cells made from patient with rare disease (long QT syndrome) Used to test new treatments

56 Ex vivo Expansion Allows for larger optimal doses for adults Useful for Gene therapy Refine stem cell separation strategy by removing hematopoietic mature and progenitor cells in order to yield pre-hematopoietic stem cells from UCB CBEs can be selected and studied for similarities and differences with ESCs 2006 CBEs isolated from fresh and frozen CBUs Expressed Nanog embryonic stem cell marker Potential for UCB-derived stem cell lines with embryonic properties

57 Pooling of UCB Stem Cells Allows adults to receive optimal doses of stem cells Research using pooled CBUs following the units that was selected as primary matched unit to engraft Possible outlet for smaller cords not suitable for allogeneic transplantation due to small cell dose

58 Treatment of Macular Degeneration Collect BM from patient and harvest stem cells Implant stem cells behind eye via retrobulbar injections under local anesthesia Re-injected cells have the potential to transform into multiple types of cells and are capable of regenerating damaged tissue

59 Other Conditions Use of UCB stem cells is currently being studied for treating conditions such as: Brain injury Type 1 Diabetes Sickle Cell Disease Research in early stages: Stoke Hearing Loss

60 Future Potential

61 Stem Cells Create Platelets! Stem cells could provide unlimited platelet supply Advanced Cell Technology, a biotechnology company, generated platelets on a large scale using human embryonic stem cells Same shape, size, and behavior both in-vitro and in mice with blood vessel injuries Future: Create platelets from ips cells Autologous donations for perfect match

62 Cord Blood Derived-DC Discovered that UCB contains dendritic cells Dendritic cells are the major antigen presenting cell (APC) that activates the immune system Current research studies show inhibitory activity on growth of human hepatocarcinoma cells in vitro and in mice Research and development for CB derived-dc vaccines for use in clinical tumor immunotherapy Market launch in discussion MatTek has developed new method for generating DC from hematopoietic stem cells harvested from UCB

63 Cord Blood/Tissue Mesenchymal Regenerative medicine Differentiate to form tissues such as bone, cartilage, tendon or muscle Laboratory trials have shown MCS to differentiate into neurons which could lead to nerve repair Phase II allogeneic MSC infusion studies show efficacy in GVHD treatment Stem Cells

64 Research on Cancer Stem Cells Two-year project between four world class research groups to collaborate on the role of cancer stem cells in the development, growth and spread of tumors in: Breast Prostrate Head and neck Cancer stem cells resistant to common therapies Spread tumor cells to other parts of body

65 $1.4 Million State Grant Boosts UCB Research One of the first grants to be funded by the Illinois Department of Public Health awarded to Loyola University Medical Center Two studies: 1) Ex vivo expansion of UCB stem cells to study Notch gene as a potential approach to treating cancer 2) Develop lymphoid precursors o o Overcome opportunistic infections associated with UCB transplants Strengthen the immune system after cord blood transplants in adults

66 Gamida Cell Launches Blood Cancer Treatment Trials Stem cell therapy products, are derived from CB to treat blood cancers, autoimmune diseases and neutropenia StemEx - phase III trial as alternate treatment to a BM transplant for blood cancer patients Market launch 2013 NiCord first trial 15 patients enrolled at Duke University

67 Stem Cell Market CB once considered medical waste is now a valuable source of stem cells More readily available and less controversial than embryonic stem cells CB stem cells show the potential to treat fatal diseases Global CB stem cells market for 2010 is estimated at about US$4.5 Billion - $15 Billion by This market makes up companies engaged in collection, processing, and banking of cord blood stem cells.

68 Imagine the future of stem cells.

69 References NMDP and CIBMTR World Marrow Donor Association (WMDA) ,0, story Zhong-Jing, S., et.al. (2005). Effects of dendritic cells from cord blood CD34+ cells on human hepatocarcinoma cell line BEL-7402 in vitro and in SCID mice. World Journal of Gastroenterology, 11,

70 BLA References Food and Drug Administration, Center for Biologics Evaluation and Research. (2009). Guidance for industry: current good tissue practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps). (21 CFR part 1270 and 1271). Retrieved from pdf Food and Drug Administration, Center for Biologics Evaluation and Research. (2008). Guidance for industry: validation of growthbased rapid microbiological methods for sterility testing of cellular and gene therapy products. (21 CFR part 1270 and 1271). Retrieved from htm Food and Drug Administration, Center for Biologics Evaluation and Research. (2009). Guidance for industry: minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications (HPC-C Licensure Guidance). Retrieved from pdf Food and Drug Administration, a proposed rule (2011). Amendments to Sterility Test Requirements for Biological Products. Federal Register, 76(119), Retrieved from Food and Drug Administration. General Biologics Standards. 21 CFR 600. Foundation for the Accreditation of Cellular Therapy. (2010). International standards for cord blood collection, banking, and release for administration accreditation manual. 4 th ed. Available from: URL: Klein M., Kadidlo D., McCullough J., McKenna D., & Burns L. J. (2006). Microbial contamination of hematopoietic stem cell products: incidence and clinical sequelae. Biol Blood Marrow Transplant, 12, Kogler, G., Callejas, J., Hakenberg, P., Enczmann, J., Adams, O., Daubener, W.,...Wernet, P. (1996). Hematopoietic transplant potential of unrelated cord blood: critical issues. Journal of Hematotherapy, 5, Mastronardi C., Perkins H., Derksen P., denadmirant M., & Ramírez-Arcos S. (2010). Evaluation of the BacT/ALERT 3D system for the implementation of in-house quality control sterility testing at Canadian Blood Services. Clin Chem Lab Med, 48, US Pharmacopeia. General information chapter 71, Cell and Gene Therapy, Rockville, MD. (2003).

71 BLA References Mancinelli F, Tamburini A, Spagnoli A, et al: Optimizing Umbilical Cord Blood Collection: Impact of Obstetric Factors Versus Quality of Cord Blood Units. Transplantation Proceedings 2006; 38: Surbek DV, Visca E, Steinmann C, et al: Umbilical cord blood collection before placental delivery during cesarean delivery increases cord blood volume and nucleated cell number available for transplantation. Am J Obstet Gynecol; 2000: Jones J, Stevens CE, Rubinstein P, et al: Obstetric predictors of placental/umbilical cord blood volume for transplantation. Am J Obstet Gynecol; 2003:503. Yamada T, Okamoto Y, et al: Factors affecting the volume of umbilical cord blood collections. Acta Obstet Gynecol Scand 2000;79: Barker, NJ et al. Transplantation of two partially HLA-matched UCB units to enhance engraftment in adults with hematologic malignancy, Blood.2005; Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products 21 CFR Amendments to Sterility Test Requirements for Biological Products, A Proposed Rule by the Food and Drug Administration on 06/21/ to-sterility-te... Good Manufacturing Practices: 210 and 211 Guidelines on General Principles of Process Validation, May 1987 Khuu, HM. et.al. Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of celltherapy products. Cytotherapy Vol. 6, No.3, Note: List is not all inclusive for BLA references.

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