cord blood banking in brazil hospital israelita albert ... › media2008 › pdf ›...

CORD BLOOD BANKING IN BRAZIL

HOSPITAL ISRAELITA ALBERT EINSTEIN’S

EXPERIENCE

JOSÉ MAURO KUTNER, MDMEDICAL DIRECTOR – BLOOD BANK

CORD BLOOD BANKING IN BRAZIL

HOSPITAL ISRAELITA ALBERT EINSTEIN’S

EXPERIENCE

JOSÉ MAURO KUTNER, MDMEDICAL DIRECTOR – BLOOD BANK

Brazil - South AmericaBrazil - South America

*

*SÃO PAULO

BARCELONA


Population 2008 193 millions2005 1,6%2007 US$ 1.3 trillions

GDP Growth 2007GDP per capita 2007 US$ 9,700Expenses with Health 2007 US$ 25.0 billions

Brazil

Population GrowthGDP – Gross Domestic Product

160% (over 2002)


Population 2008 193 millions2005 1,6%2007 US$ 1.3 trillions

GDP Growth 2007GDP per capita 2007 US$ 9,700Expenses with Health 2007 US$ 25.0 billions

Brazil

Population GrowthGDP – Gross Domestic Product

160% (over 2002)

9th economy in the world

Brazilian PopulationBrazilian 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 BrazilLife Expectancy in Brazil

68,9

63,166

606264666870

1980 1990 2000

• 2003: 6,5 millions > 60 years old

• 2025: 25 millions > 60 years old

SÃO PAULO, BRAZILSÃO 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




Characteristics

* General Hospital (Jewish Community)* Non-profit institution, private institution* Foundation 1970* 334th largest company in the country

(sales) *

* 2007 sales = US$ 400 millions

* Revista Exame 01/08/2008



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



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)




* 90 employees* 12,000 whole blood collections / year* 1,200 platelet pheresis / year* 950 cord blood donations / year




• 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 Bankspresently Advancing Transfusion and Cellular Therapies Worldwide

CORD BLOOD BANKING

* HOSPITAL ISRAELITA ALBERT EINSTEIN

* BRAZIL

CORD BLOOD BANKING ATHOSPITAL ALBERT EINSTEIN CORD BLOOD BANKING AT

HOSPITAL ALBERT EINSTEIN

• 2001 – 2004

PRIVATE CORD BLOOD BANKING

• 2004 – PRESENT

PUBLIC CORD BLOOD BANKING


HOSPITAL ALBERT EINSTEIN • 2001 – 2004


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


HOSPITAL ALBERT EINSTEIN • 2001 – 2004


- 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


HOSPITAL ALBERT EINSTEIN • 2004 - PRESENT


- 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)




- 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




- ALL CENTERS WITH BIOARCHIVES (3)

- PROGESA (MAK-SYSTEM´S SOFTWARE) UNDER IMPLEMENTATION

- RE-EQUIPMENT OF HIAE´S HLA LABORATORY – LUMINEX

- SEPACS system




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)



38

237

83

940 989 952

806

104

0

200

400

600

800

1000

1200

à partir deout/2004

2005 2006 2007 jan-nov / 2008

CB Units - Hosp. Campo Limpo since oct/06

CB Units - Hosp. Isr. Albert Einstein since oct/04

38

237

83

940 989 952

806

104

0

200

400

600

800

1000

1200

à partir deout/2004

2005 2006 2007 jan-nov / 2008

CB Units - Hosp. Campo Limpo since oct/06

CB Units - Hosp. Isr. Albert Einstein since oct/04



42

290

220

200

400

600

800

1000

1200

2007 2008

CB Units Campinas Blood Center CB Units Ribeirão Preto Blood Center

42

290

220

200

400

600

800

1000

1200

2007 2008

CB Units Campinas Blood Center CB Units Ribeirão Preto Blood Center




1,461 AVAILABLE FOR USE (HLA/TX DX TESTING)

MAIN LIMITATION FOR AVAILABILITY :

QUARANTINE PERIOD (2nd SET OF TX DX TESTING ) > 2 MONTHS AFTERDONATION



CORD BLOOD UNITS SENT FOR TRANSPLANTATIONBY HIAE

46 UNITS

35 ENGRAFTED2 DIED BEFORE BMT9 WAITING FOR REPORTS

Bone Marrow Transplantationin Brazil


BONE MARROW TRANSPLANTATION AT HOSPITAL ALBERT EINSTEIN

• PROGRAM STARTED 1987

• TRANSPLANTS PERFORMED = 573

431 AUTOLOGOUS

ALLOGENEIC 99BM/PBSC

43 ALLOGENEIC CORD BLOOD ( 7 DOUBLE CB)

Bone Marrow Transplantation

Cord Blood Banking

In Brazil

Bone Marrow Transplantation

Cord Blood Banking

In Brazil

Bone Marrow Transplantation in BrazilBrazilian Law on BMT / CBBanking


• Law RDC 153 June 2004

- 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)

- mother must be submitted to Tx Disease Testing

- Tx Dx Testing :

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)

- 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 108 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

– 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

• BMT / patients

– 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



55 Centers for BMT

MEDICAL CENTERS FOR BMT IN BRAZIL

15 non related

Dr. L.F.Bouzas

0100.000200.000300.000400.000500.000600.000700.000800.000900.000

1.000.000

até2000

2001 2002 2003 2004 2005 2006 2007 2008

940,000 DONORS REGISTERED

R E D O M E - DONORS REGISTERED UNTIL DEC / 2008OBS. 2007 DATA JAN-MAY ONLY

Dr. L.F.Bouzas



OESP – 30 dez 08 and

Cord Blood Transplantationin Brazil


RENACORD

Hosp. Albert Einstein

São Paulo

Blood CtrCampinas

(8 more planned)

INCARio de Janeiro

Blood CtrCampinas

Campinas

Blood CtrRib.Preto

Ribeirão Preto

REDOME Brazilian National Marrow Registry

Transplant Center Transplant Center

Dr. L.F.Bouzas

Cord Blood Collection CentersCord Blood Collection Centers

* **

*

Rio de Janeiro

São Paulo

Ribeirão Preto

Campinas

** *

***

* 8 more planned

Cord Blood Collection CentersCord Blood Collection Centers

* **

*

Rio de Janeiro

São Paulo

Ribeirão Preto

Campinas

** *

***

* 8 more planned Rio Grande do Sul

Santa Catarina

Paraná

Minas Gerais

Brasília

Pernambuco

Maranhão

Pará

PROJETO REDOME

Dr. José Roberto Moraes

Brazilian Ethnic DiversityBrazilian Ethnic Diversity

* **

**

* **

**SOUTH- Europeans :

portuguesegermansitaliansoriental Europe

SOUTHEAST- Europeans :

portuguesegermansitaliansspanishjapanese

NORTHEAST- Europeans

portuguese- Africans

NORTH- Indians- Africans- Europeans

Source: Wikipedia, 2009

Brazilian Ethnic DiversityBrazilian Ethnic Diversity

* **

**

* **

**SOUTH- Europeans :

portuguesegermansitaliansoriental Europe

SOUTHEAST- Europeans :

portuguesegermansitaliansspanishjapanese

NORTHEAST- Europeans

portuguese- Africans

NORTH- Indians- Africans- Europeans

Ethnic Groups:- white 49 %- mulato 43 %- black 7 %- indians 0.3 %- yellow 0.5 %

Source: Wikipedia, 2009



GOALS :

• REACH 60,000 UNITS WITHIN THE SYSTEM (12 CENTERS);

• INTEGRATION WITH INTERNATIONAL REGISTRIES

Dr. L.F.Bouzas

Source: HEMO em revista #6-2008 p.45




PRESENT INVENTORY WITHIN 4 INSTITUTIONS OPERATING:

8,868 CORD BLOOD UNITS COLLECTED


2,529 UNITS AVAILABLE FOR USE (HLA + TX DX TESTING)



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

Neutrophils and Platelets EngraftmentNeutrophils and Platelets EngraftmentDr. L.F.Bouzas





OVERALL SURVIVALwith CB Tx

Dr. L.F.Bouzas



Overall Survival withNon Related

Hematopoietic Stem Cells (2007)BM vs PBSC vs CB

( 287 Tx)

Overall Survival withNon Related

Hematopoietic Stem Cells (2007)BM vs PBSC vs CB

( 287 Tx)

N Median OS 95% CI

BM 142 5.36 3.42 to 7.30

PB 31 3.23 1.08 to 5.38

CB 114 4.90 2.44 to 7.35

p = 0.27

Dr. L.F.Bouzas

CB Collection TeamHospital Albert Einstein

Hematopoietic Progenitor Cells TeamHospital 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 [email protected]

cord blood banking in brazil hospital israelita albert ... › media2008 › pdf ›...

Documents