CORD BLOOD BANKING IN BRAZIL HOSPITAL ISRAELITA ALBERT EINSTEIN S EXPERIENCE

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1 CORD BLOOD BANKING IN BRAZIL HOSPITAL ISRAELITA ALBERT EINSTEIN S EXPERIENCE JOSÉ MAURO KUTNER, MD MEDICAL DIRECTOR BLOOD BANK

2 Brazil - South America BARCELONA * * SÃO PAULO

3 Brazil - South America Brazil Population millions Population Growth ,6% GDP Gross Domestic Product 2007 US$ 1.3 trillions GDP Growth % (over 2002) GDP per capita 2007 US$ 9,700 Expenses with Health 2007 US$ 25.0 billions

4 Brazil - South America Brazil Population millions Population Growth ,6% GDP Gross Domestic Product 2007 US$ 1.3 trillions GDP Growth % (over 2002) GDP per capita 2007 US$ 9,700 Expenses with Health 2007 US$ 25.0 billions 9 th economy in the world

5 Brazilian Population DEMOGRAPHIC INDICATORS 2007 Birth Rate 20.4 / 1,000 Child Mortality Rate (/1,000) 25 / 1,000 Life Expectancy Men 67.9 years Women 75.5 years

6 Life Expectancy in Brazil , , : 6,5 millions > 60 years old 2025: 25 millions > 60 years old

7 SÃO PAULO, BRAZIL SÃO PAULO, BRAZIL * largest city in Brazil * 11 million inhabitants (18 millions in Great SP) * southeast region * strong economy = industries, services

8 HOSPITAL ISRAELITA ALBERT EINSTEIN

9 HOSPITAL ISRAELITA ALBERT EINSTEIN Characteristics * General Hospital (Jewish Community) * Non-profit institution, private institution * Foundation 1970 * 334 th largest company in the country (sales) * * 2007 sales = US$ 400 millions * Revista Exame 01/08/2008

10 HOSPITAL ISRAELITA ALBERT EINSTEIN * Beds = 460 (2008) 700 (2010) * Surgeries/year = 26,000 * Deliveries/year = 3,100 * Liver Transplantations / year = 115 * Total Transplantations / year = 210 * Employees = 6,700

11 HOSPITAL ISRAELITA ALBERT EINSTEIN

12 HOSPITAL ISRAELITA ALBERT EINSTEIN

13 HOSPITAL ISRAELITA ALBERT EINSTEIN

14 HOSPITAL ISRAELITA ALBERT EINSTEIN

15 HOSPITAL ISRAELITA ALBERT EINSTEIN BLOOD BANK (Hemotherapy Department) * collects all the Hospital s needs * pheresis program (donations and therapeutics) * perioperative salvage * stem cell program * cord blood program (public) * performs all tx dx testing (incl. NAT HIV/HCV) * immunohematology lab (incl. molecular biology) * cryopreservation lab (BM/PBSC/CB)

16 HOSPITAL ISRAELITA ALBERT EINSTEIN BLOOD BANK (Hemotherapy Department) * 90 employees * 12,000 whole blood collections / year * 1,200 platelet pheresis / year * 950 cord blood donations / year

17 HOSPITAL ISRAELITA ALBERT EINSTEIN BLOOD BANK (Hemotherapy Department) ISO 9000 certified since 1997; AABB accredited since 1998 (scope includes donor center / transfusion services / hematopoietic progenitor cells / cord blood) ; AABB Imunohematology Reference Lab accredited since 2008 US Joint Commission accredited since 2000 working for FACT accreditation AABB = former American Association of Blood Banks presently Advancing Transfusion and Cellular Therapies Worldwide

18 CORD BLOOD BANKING * HOSPITAL ISRAELITA ALBERT EINSTEIN * BRAZIL

19 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRIVATE CORD BLOOD BANKING 2004 PRESENT PUBLIC CORD BLOOD BANKING

20 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRIVATE CORD BLOOD BANKING WHY PRIVATE BANKING? - UNAVAILABILITY OF FUNDING FOR PUBLIC BANK - STRONG DEMAND FROM HOSPITAL S PATIENTS (PRIVATE) - AT THAT TIME, UNAVAILABILITY OF OTHER PRIVATE BANKS - AVAILABILITY OF THE METHODOLOGY AT HOSPITAL ALBERT EINSTEIN

21 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRIVATE CORD BLOOD BANKING - APPROXIMATELY 1050 PRIVATE UNITS FROZEN - PROGRAM CLOSED ON SEPTEMBER 2004: * NO CLEAR BENEFITS PROVEN FOR PATIENTS * AVAILABILITY OF OTHER PRIVATE BANKS * GOAL TO DEVELOP A PUBLIC BANK * PUBLIC BANK WOULD HAVE STRONGER BENEFIT FOR THE POPULATION

22 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRESENT PUBLIC CORD BLOOD BANKING - HOSPITAL S OWN FUNDING - APPROXIMATELY US$ 20 MILLIONS - COLLECT, PROCESS, FREEZE 12,000 UNITS - 3 CENTERS FUNDED BY HIAE: * HOSPITAL ALBERT EINSTEIN, SÃO PAULO (PRIVATE) * CAMPINAS BLOOD CENTER, CAMPINAS (PUBLIC) * RIBEIRÃO PRETO BLOOD CENTER, RIBEIRÃO PRETO (PUBLIC)

23 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRESENT PUBLIC CORD BLOOD BANKING - 3 CENTERS FUNDED BY HIAE: HOSPITAL ALBERT EINSTEIN, SÃO PAULO OPERATING SINCE OCTOBER / 2004 CAMPINAS BLOOD CENTER, CAMPINAS OPERATING SINCE JULY / 2007 RIBEIRÃO PRETO BLOOD CENTER, RIBEIRÃO PRETO OPERATING SINCE AUGUST / 2008

24 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRESENT PUBLIC CORD BLOOD BANKING - ALL CENTERS WITH BIOARCHIVES (3) - PROGESA (MAK-SYSTEM S SOFTWARE) UNDER IMPLEMENTATION - RE-EQUIPMENT OF HIAE S HLA LABORATORY LUMINEX - SEPACS system

25 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRESENT PUBLIC CORD BLOOD BANKING OCTOBER / 2004 NOVEMBER / 2008: 4,154 CORD BLOOD UNITS COLLECTED 3,052 CORD BLOOD UNITS FROZEN 1,461 UNITS AVAILABLE FOR USE (HLA + TX DX TESTING)

26 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN à partir de out/ jan-nov / 2008 CB Units - Hosp. Campo Limpo since oct/06 CB Units - Hosp. Isr. Albert Einstein since oct/04

27 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN CB Units Campinas Blood Center CB Units Ribeirão Preto Blood Center

28 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 3,052 CORD BLOOD UNITS FROZEN 1,461 AVAILABLE FOR USE (HLA/TX DX TESTING) MAIN LIMITATION FOR AVAILABILITY : QUARANTINE PERIOD (2nd SET OF TX DX TESTING ) > 2 MONTHS AFTER DONATION

29 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN CORD BLOOD UNITS SENT FOR TRANSPLANTATION BY HIAE 46 UNITS 35 ENGRAFTED 2 DIED BEFORE BMT 9 WAITING FOR REPORTS

30 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN

31 Bone Marrow Transplantation in Brazil BONE MARROW TRANSPLANTATION AT HOSPITAL ALBERT EINSTEIN PROGRAM STARTED 1987 TRANSPLANTS PERFORMED = 573 ALLOGENEIC 99 BM/PBSC 43 ALLOGENEIC CORD BLOOD ( 7 DOUBLE CB) 431 AUTOLOGOUS

32 Bone Marrow Transplantation Cord Blood Banking In Brazil

33 Law RDC 153 June 2004 Bone Marrow Transplantation in Brazil Brazilian Law on BMT / CBBanking - rules hemotherapy, incl. human blood / marrow / cord blood - all technical aspects of the procedures - donation must be sigilous (recipient can t know the donor) - non-paid donation - donor must sign informed consent - donor > 18 y.o. < 36 y.o. - gestational age > 35 weeks - fetus > 2 kg - no infection / malformation / congenital abnormalities / known hereditary diseases /

34 Law RDC 153 June 2004 (cont d) Bone Marrow Transplantation in Brazil Brazilian Law on BMT / CBBanking - mother must be submitted to Tx Disease Testing - TxDxTesting : same as for Whole Blood = -HIV - HCV - HBV - Chagas - Syphilis - Hemoglobin Electrophoresis + CMV IgM / Toxoplasmosis IgM / Bacterial Culture - test for Phenylcetonuria + Hypothyroidism + Sickle Cell Disease

35 Law RDC 153 June 2004 (cont d) Bone Marrow Transplantation in Brazil Brazilian Law on BMT / CBBanking - Tx Disease Testing at donation AND > 2 months after birth - child must be submitted to medical examination > 2 months after birth - nucleated cells > 5 x 10 8 OR volume > 70 ml - also rules autologous and directed collections Every use of CB must go through the Government, even if from abroad (Nat l Cancer Institute Rio de Janeiro) Governm t rules export / import of CB

36 BMT / patients Bone Marrow Transplantation in Brazil Present needs for BMT (estimate) 5100 / year Patients with a related donor 1785 / year Patients without a related donor 3315 / year BMT 1500 / year Patients without an available source of HPC ~ 1700 a 2000/year Dr. L.F.Bouzas

37 MEDICAL CENTERS FOR BMT IN BRAZIL Bone Marrow Transplantation in Brazil 55 Centers for BMT 15 non related Dr. L.F.Bouzas

38 Bone Marrow Transplantation in Brazil até ,000 DONORS REGISTERED R E D O M E - DONORS REGISTERED UNTIL DEC / 2008 OESP 30 dez 08 and Dr. L.F.Bouzas OBS DATA JAN-MAY ONLY

39 Cord Blood Transplantation in Brazil INCA Rio de Janeiro Hosp. Albert Einstein São Paulo Blood Ctr Campinas Campinas Blood Ctr Rib.Preto Ribeirão Preto (8 more planned) RENACORD REDOME Brazilian National Marrow Registry Transplant Center Transplant Center Dr. L.F.Bouzas

40 Cord Blood Collection Centers Rio de Janeiro Ribeirão Preto * * * * São Paulo Campinas * 8 more planned

41 Cord Blood Collection Centers Pará Maranhão Pernambuco Brasília Ribeirão Preto Campinas Minas Gerais * * * * Paraná Santa Catarina São Paulo Rio de Janeiro * 8 more planned Rio Grande do Sul

42 PROJETO REDOME Dr. José Roberto Moraes

43 Brazilian Ethnic Diversity NORTH - Indians - Africans - Europeans NORTHEAST - Europeans portuguese - Africans Source: Wikipedia, 2009 SOUTH - Europeans : portuguese germans italians oriental Europe * * * * SOUTHEAST - Europeans : portuguese germans italians spanish japanese

44 Brazilian Ethnic Diversity NORTH - Indians - Africans - Europeans NORTHEAST - Europeans portuguese - Africans Ethnic Groups: - white 49 % - mulato 43 % - black 7 % - indians 0.3 % - yellow 0.5 % Source: Wikipedia, 2009 SOUTH - Europeans : portuguese germans italians oriental Europe * * * * SOUTHEAST - Europeans : portuguese germans italians spanish japanese

45 Cord Blood Transplantation in Brazil GOALS : REACH 60,000 UNITS WITHIN THE SYSTEM (12 CENTERS); INTEGRATION WITH INTERNATIONAL REGISTRIES Source: HEMO em revista # p.45 Dr. L.F.Bouzas

46 Cord Blood Transplantation in Brazil PUBLIC CORD BLOOD BANKING PRESENT INVENTORY WITHIN 4 INSTITUTIONS OPERATING: 8,868 CORD BLOOD UNITS COLLECTED 6,079 CORD BLOOD UNITS FROZEN 2,529 UNITS AVAILABLE FOR USE (HLA + TX DX TESTING)

47 Cord Blood Transplantation in Brazil UNTIL JUNE / 2008 : - 56 BMT PERFORMED WITH CORD BLOOD UNITS ORIGINATED FROM BRASILCORD (incl. Hosp.Alb.Einstein s) BMT PERFORMED WITH CBU ORIGINATED ABROAD Source: HEMO em revista # p.45

48 Cord Blood Transplantation in Brazil Neutrophils and Platelets Engraftment Dr. L.F.Bouzas

49 Cord Blood Transplantation in Brazil OVERALL SURVIVAL with CB Tx Dr. L.F.Bouzas

50 Cord Blood Transplantation in Brazil Overall Survival with Non Related Hematopoietic Stem Cells (2007) BM vs PBSC vs CB ( 287 Tx) p = 0.27 N Median OS 95% CI BM to 7.30 Dr. L.F.Bouzas PB to 5.38 CB to 7.35

51 CB Collection Team Hospital Albert Einstein Hematopoietic Progenitor Cells Team Hospital Albert Einstein - Dr. Luiz Fernando Bouzas National Cancer Institute, Rio de Janeiro - Hospital Israelita Albert Einstein's BMT/ Hemotherapy Teams/ Dra Andreza Ribeiro

52 GRACIAS / GRÀCIES kutner@einstein.br

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