CORD BLOOD BANKING IN BRAZIL HOSPITAL ISRAELITA ALBERT EINSTEIN S EXPERIENCE JOSÉ MAURO KUTNER, MD MEDICAL DIRECTOR BLOOD BANK
Brazil - South America BARCELONA * * SÃO PAULO
Brazil - South America Brazil Population 2008 193 millions Population Growth 2005 1,6% GDP Gross Domestic Product 2007 US$ 1.3 trillions GDP Growth 2007 160% (over 2002) GDP per capita 2007 US$ 9,700 Expenses with Health 2007 US$ 25.0 billions
Brazil - South America Brazil Population 2008 193 millions Population Growth 2005 1,6% GDP Gross Domestic Product 2007 US$ 1.3 trillions GDP Growth 2007 160% (over 2002) GDP per capita 2007 US$ 9,700 Expenses with Health 2007 US$ 25.0 billions 9 th economy in the world
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
Life Expectancy in Brazil 70 68 66 64 62 60 68,9 66 63,1 1980 1990 2000 2003: 6,5 millions > 60 years old 2025: 25 millions > 60 years old
SÃO PAULO, BRAZIL SÃO PAULO, BRAZIL * largest city in Brazil * 11 million inhabitants (18 millions in Great SP) * southeast region * strong economy = industries, services
HOSPITAL ISRAELITA ALBERT EINSTEIN
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
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
HOSPITAL ISRAELITA ALBERT EINSTEIN
HOSPITAL ISRAELITA ALBERT EINSTEIN
HOSPITAL ISRAELITA ALBERT EINSTEIN
HOSPITAL ISRAELITA ALBERT EINSTEIN
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)
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
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
CORD BLOOD BANKING * HOSPITAL ISRAELITA ALBERT EINSTEIN * BRAZIL
2001 2004 CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN PRIVATE CORD BLOOD BANKING 2004 PRESENT PUBLIC CORD BLOOD BANKING
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2001 2004 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
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2001 2004 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
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2004 - 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)
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2004 - 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
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2004 - 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
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 2004 - 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)
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 1200 1000 800 940 989 952 806 600 400 200 0 104 à partir de out/2004 237 83 38 2005 2006 2007 jan-nov / 2008 CB Units - Hosp. Campo Limpo since oct/06 CB Units - Hosp. Isr. Albert Einstein since oct/04
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN 1200 1000 800 600 400 200 0 290 42 22 2007 2008 CB Units Campinas Blood Center CB Units Ribeirão Preto Blood Center
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
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
CORD BLOOD BANKING AT HOSPITAL ALBERT EINSTEIN
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
Bone Marrow Transplantation Cord Blood Banking In Brazil
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 /
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
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
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 - 2007
MEDICAL CENTERS FOR BMT IN BRAZIL Bone Marrow Transplantation in Brazil 55 Centers for BMT 15 non related Dr. L.F.Bouzas
Bone Marrow Transplantation in Brazil 1.000.000 900.000 800.000 700.000 600.000 500.000 400.000 300.000 200.000 100.000 0 até 2000 2001 2002 2003 2004 2005 2006 2007 2008 940,000 DONORS REGISTERED R E D O M E - DONORS REGISTERED UNTIL DEC / 2008 OESP 30 dez 08 and Dr. L.F.Bouzas OBS. 2007 DATA JAN-MAY ONLY
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
Cord Blood Collection Centers Rio de Janeiro Ribeirão Preto * * * * São Paulo Campinas * 8 more planned
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
PROJETO REDOME Dr. José Roberto Moraes
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
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
Cord Blood Transplantation in Brazil GOALS : REACH 60,000 UNITS WITHIN THE SYSTEM (12 CENTERS); INTEGRATION WITH INTERNATIONAL REGISTRIES Source: HEMO em revista #6-2008 p.45 Dr. L.F.Bouzas
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)
Cord Blood Transplantation in Brazil UNTIL JUNE / 2008 : - 56 BMT PERFORMED WITH CORD BLOOD UNITS ORIGINATED FROM BRASILCORD (incl. Hosp.Alb.Einstein s) - 182 BMT PERFORMED WITH CBU ORIGINATED ABROAD Source: HEMO em revista #6-2008 p.45
Cord Blood Transplantation in Brazil Neutrophils and Platelets Engraftment Dr. L.F.Bouzas
Cord Blood Transplantation in Brazil OVERALL SURVIVAL with CB Tx Dr. L.F.Bouzas
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 142 5.36 3.42 to 7.30 Dr. L.F.Bouzas PB 31 3.23 1.08 to 5.38 CB 114 4.90 2.44 to 7.35
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
GRACIAS / GRÀCIES kutner@einstein.br