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CORD BLOOD History and Future

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Slide 1 :

CORD BLOODHistory and Future Presented by Carolyn T. Young, M.D. Vice President and Chief Medical Officer Rhode Island Blood Center

Slide 2 :

CORD BLOOD 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

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CORD BLOOD Rich source of stem cells from all ethnic groups Readily available 1988: First successful cord blood sibling-sibling transplant was for Fanconi’s anemia May treat many diseases including: leukemia, lymphoma, sickle cell anemia Estimates of the risk of needing stem cell transplant range from 1:1000-1:200,000 per ACOG and AAP

Slide 4 :

CORD BLOOD Current thoughts Indefinite storage frozen in liquid nitrogen Perfect HLA match is not needed unlike marrow transplants Increases the probability of finding an acceptable donor cord blood Less Graft vs Host Disease in transplanted recipients

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CORD BLOOD Best predictor of engraftment is the total nucleated cell count present in the original collection, i.e. cell dose The more donor cells per recipient weight the better chance of successful engraftment Limitation of size of recipient, <40 kg, for single cord transplants Increases the probability of finding an acceptable donor for transplant since the HLA match does not need to be identical

Slide 6 :

CORD BLOOD Future thoughts Many adult leukemia patients may be eligible for umbilical cord blood transplantation by using multiple cord bloods Research done combining two units, median dose 35 million nucleated cells/kg, found 21/23 transplants successfully engrafted Barker, NJ et al. Transplantation of two partially HLA-matched UCB units to enhance engraftment in adults with hematologic malignancy, Blood.2005;105-1343-1347

Slide 7 :

CORD BLOOD May be useful in Tissue Engineering (TE), a process controlling cell behavior to allow their implantation along with non-biologic scaffolds, in place of traditional synthetic prostheses, to repair and reconstruct tissue Examples: Blood Vessels, Heart Valves, Muscle, Cornea

Slide 8 :

CORD BLOOD Tissue Engineered Vascular Grafts Start with cell source of desired cell function, e.g. endothelial progenitor cells from bone marrow, blood or cord blood Construct cell-scaffold interaction to mimic natural environment, i.e. pulsatile blood flow and pressure Still 5-10 years from FDA approval Vascular Medicine 2002; 7:241-246 TE Pulmonary Artery, Shin’oka T, NEJM 2001;344:532-3

Slide 9 :

CORD BLOOD Stem Cell Transplantation in Myocardial Infarction (MI) Lee MS et al, Ann Int Med 2004; 140:729-37 Staurer BE, et al. Circulation 2002:106:1913-8 Intracoronary transplantation of autologous, mononuclear bone marrow cells subsequent to an acute anterior MI showed improved myocardial perfusion Maybe cord blood could be a source for allogeneic repair research?

Slide 10 :

CORD BLOOD Cord Blood Stem Cell Act of 2005 Introduced in Congress Tremendous potential to save lives

Slide 11 :

Patricia Lang, MS, MT(ASCP)Director of Marrow Donor ProgramRhode Island Blood Center

Slide 12 :

Stem Cell Therapeutic & Research Act of 2005 Sen. Jack Reed one of key sponsors Reauthorizes National Marrow Donor Program with expanded scope

Slide 13 :

Stem Cell Therapeutic & Research Act of 2005 structure & funding

Slide 14 :

Stem CellSources & Therapeutic Use Bone marrow Peripheral Blood Umbilical Cord Blood Treatment for 60 + diseases (cancerous & genetic)

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Challenges to Transplantation Matched stem cells needed Fewer minority patients have matches * 45% of African-Americans find matched donors compared to 90% of caucasians

Slide 16 :

Solutions Caucasians without matched adult donor can use double cord blood units Cord blood can close minority gap

Slide 17 :

Cord Blood Banks (CBB) 20 NMDP public CBB 56,000 cords listed 60 cords distributed / month 15% of total NMDP transplants & increasing 1 satellite in Worcester, MA Dana Farber soon to open ~ 6 non-NMDP public CBB 15-20 private CBB

Slide 18 :

Reimbursement for Cord Blood Unit(CBU) Transplant Center requests CBU from NMDP Cord Blood Bank (CBB) NMDP requests & pays CBB ($15,500 - $26,000) Transplant Center charges patient / insurance company for CBU

Slide 19 :

State Legislation to: Create public cord blood banks (NJ, TX, VA, CT, GA) Support stem cell research (NJ, CT, CA, VA, GA) Increase awareness of donation option (NJ, NM, WI, GA, IL)

Slide 20 :

GA Senate Bill 148 Creates CBB or network of banks Requires informing pregnant women of opportunity to donate Passed 1 committee but may get stuck in Rules Committee due to controversy over embryonic cells

Slide 21 :

CT Legislation 4/06 Public Act 06-77 created commission to study & report on CBB House Bill 7158 & Senate Bill 311 proposed 1/07 will fund CBB Cords will be provided to CT researchers at no charge

Slide 22 :

NJ Legislation Publicly funded CBB $300,000 for education & outreach $150 million to build research center 2 processing & storage facilities Cords provided free to NJ researchers

Slide 23 :

State Legislative Activity Increasing(2/2/07 AP article by Vinnee Tong) 10 states have passed laws related to cord blood donation & banking 12 states are expected to consider legislation in 2007

Slide 24 :

Public Cord Blood Banks Satisfy public desire to donate Provide cord blood for transplantation Give minority patients more options Provide cord blood for research

Slide 25 :

Rhode Island Blood Center

Slide 26 :

Rhode Island Blood Center 501c(3) not for profit Board of Trustees 11 hospital CEO’s or designees 11 community representatives

Slide 27 :

RIBC, by the numbers 5 Donor Centers 1,470 blood drives / year 100,000 blood donations 240,000 products manufactured 5 testing laboratories in Providence 1.3 million tests 365 employees

Slide 28 :

RIBC – Industry Leader Blood Collections National average 55/1000 pop. RIBC 95/1000 pop. 25% from automated technology Exceptional donor satisfaction

Slide 29 :

RIBC – Industry Leader Blood product manufacturing 100% leukoreduction, RBC’s and platelets 100% bacterial testing of platelets HLA Antibody screening to minimize TRALI

Slide 30 :

RIBC – Industry Leader Laboratory Services – on site Infectious disease testing Lab Nucleic Acid Amplification Lab (NAT) Human Leukocyte Antigen Lab (HLA) Red Cell Reference Lab DNA Lab

Slide 31 :

RIBC Testing Capabilities Infectious Disease Testing High throughput automated testing platforms Hepatitis B Surface Antigen Hepatitis B Core Antibody HIV 1/2 Antibody Hepatitis C Antibody HTLV 1/2 CMV Antibody Syphilis Nucleic Acid Amplification Testing HIV / HCV WNV Blood typing , ABO, Rh,

Slide 32 :

Licensure and Accreditation FDA #878 RI #150 AABB member #936 CLIA #41D0670559 ASHI #01-1-RI-01-1 NMDP

Slide 33 :

Accreditations American Society for Histocompatibility and Immunogenetics (ASHI) Accredited Human Leukocyte Antigen (HLA) Lab Testing: Serology Typing: Class I DNA Typing: Class I Low resolution SSP DNA Typing: Class II Low resolution and High resolution SSP Antibody Screening/Identification: Class I and II, CDC, microarray Crossmatching: T cells- CDC, AHG B cells- CDC Luminex HLA antibody screening

Slide 34 :

AABB Accreditation Blood Collection Activities Hematopoietic Progenitor Cell (HPC) collections Parentage Testing Reference Laboratory

Slide 35 :

ASHI Accreditation HSC/BM Transplantation: Related Donor Solid Organ Transplantation: Live Donor Transfusion Support Histocompatibility testing for other clinical purposes.

Slide 36 :

Other Programs Rhode Island Marrow Donor Program (MDP) 37,000 registered donors with 29 peripheral blood stem cell procedures performed by Rhode Island Blood Center staff in Fiscal Year 2006. The Rhode Island Blood Center MDP, is rated a "high performing" center in quality assurance indicators as measured against national standards by NMDP.

Slide 37 :

Recent Research Collaborations HPV Vaccine Associate Investigator in phase I study of immunization with altering HPV E7 lipopeptide epitope vaccine and dendritic cells presenting the E7 epitope for the treatment of recurrent or persistent cervical cancer (NCI T98-0072) Dendritic Cell Research Collection NMDP-PBSC protocol

Slide 38 :

RIBC Regional Cord Blood Program- Advantages In region location and management Use existing infrastructure Accelerate startup time Achieve greater diversity Committed product inventory research transplant

Slide 39 :

RIBC’s Interest in Cord Blood Future of transplant medicine Support research Consistent with Mission/Vision

Slide 40 :

RIBC can offer Established relationship with hospitals Donor recruitment/ PR expertise Product collection standardization Training SOP’s Medical/Technical/Testing expertise Complete In house

Slide 41 :

RIBC can offer Processing / Inventory management On site cGMP environment Regional distribution Established systems 24/7 Customer Service and Support Research and transplant

Slide 42 :

Financial/Operational Estimates To Establish Viable Public Cord Blood Bank $10 million over 5 years Self sustaining > 5years

Slide 43 :

RIBC cannot offer Start up funding Ongoing financial subsidy Guarantee of financial success

Slide 44 :

Challenges for the Commission Secure 5 year funding Private , foundations, corporations etc.. Public , already strained healthcare $’s Secure commitment from hospitals

Wael on Jan 27, 2010 Says :

thnaks for this presentation it was useful fro my, thanks again

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Stem cells generate various cell lines; Sources of stem cells: bone marrow,lymphoma, sickle cell an more Stem cells generate various cell lines; Sources of stem cells: bone marrow,lymphoma, sickle cell anemia; Estimates of the risk of needing stem cell … less