Public Umbilical Cord Blood Banking Project

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Siriraj Cord Blood Banking Project
Introduction
Hematopoietic stem cell transplantation was first established in Thailand in 1986
at Siriraj Hospital. Since then, more than 1000 lifes were saved in 4 medical centers in
the country. Allogeneic1 stem cell transplantation needs a donor to donate HLA-matched
stem cells to the patient. Although some patients have a family member who can donate
cells, nearly 75% of patients will not find a matching donor in their family. Thus, Cord
blood donations can give more patients hope of finding a match
In recent years, umbilical cord blood, which contains a large number of
hematopoietic stem cells, has been used successfully for allogeneic transplantation to
treat a variety of pediatric genetic, hematologic, and oncologic disorders. It is a potential
alternative when autologous or allogeneic transplantation with HLA-matched marrow is
unavailable for children. This advance has resulted in the establishment of cord blood
banking programs for autologous and allogeneic transplantation. The American
Academy of Pediatrics1 has makes recommendations about appropriate ethical and
operational standards, including informed consent policies, for the institutions that
operate a program of cord blood banking.
The Faculty of Medicine, Siriraj Hospital’s policy is committed to supporting the
health of Thai people. Recruitment of as much cord blood unit as possible would increase
the chance of finding a suitably matched donor. Even though more than 100,000 cord
blood unit registed worldwide, most of the Thai patients still can’t find a matched
because some tissue traits are more likely to be found among people of a particular racial
or ethnic heritage, not to mention the extremely high cost and the complicated process to
access. That is why a pressing need remains for more cord blood donations among the
Thai community.
The Thai Red Cross Society has established a National Stem Cell Donor Registry
Program since May 2003 from the list of adult blood donor volunteers. The program
registed more than 5000 adult stem cell donors (peripheral blood or bone marrow
donation) within 3 years, but the expansion of cord blood donation is very limited. Siriraj
Hospital is the most suitably qualified and experienced institute for setting up a public
cord blood banking in Thailand. Not only that Siriraj has a large number of birth per year,
but also it has the competency and full complement of other facilities, including Blood
bank, clinical departments, stem cell transplantation units and all essential laboratories.
As per Executive Board of Siriraj’s vision to be a leading health institute in
South-East Asia, this project is to set up the first International Standard Umbilical Cord
Blood Bank in Thailand. Its difference resource of Hematopoietic stem cells from the
Thai Red Cross Society will benefit the Nation’s Stem Cell Donor Policy.
1
From other person
Name
Siriraj Cord Blood Stem Cell Bank Project.
Vision
“New life, new chance”
Mission
Siriraj CBSCB project will expand and maximize the national cord
blood inventory in Thailand
Objective
To establish a public cord blood bank in Siriraj Hospital
Action Plan
1. Establish a UCB Policy Board and Financial Support Committee
2. Establish a Cord Blood Coordination Center
3. Establish a public umbilical cord blood bank (UCBB) at Siriraj Hospital by the
year 2007
4. Join the National Donor Registry Networking in Thailand
The Policy
A Policy and Ethic Committee should be set up by the faculty to make
recommendations about appropriate ethical and operational standards, including inform
consent policies, the security of medical information and cord blood donor’s rights.
The Process
Registry
All of the data in the Registry are managed by the Siriraj UCBB center by using a
proprietary software system to track detailed patient history and maintains donor
information.
Collecting Cord Blood Donations
The collecting of cord blood from the Department of Ob-Gyn through a standard
institutional protocol.
Informed Consent
The umbilical cord blood is considered to belong to the infant, and the mother gives
consent on behalf of her child. The mother must sign an informed consent to donate the
cord blood is collected. Donation must be voluntary, confidential and uncompensated.
Collection Procedures
The goal when collecting cord blood is to collect the maximum number of hematopoietic
progenitor cells possible while in no way disrupting the normal activities of the
obstetrician in the peripartum period. The number of cells is important to the success of
the transplant. The transplant recipient's time to neutrophil recovery is strongly correlated
with the dose of cryopreserved nucleated cells, CFU-GM and the dose of thawed CD34+
cells (3). To accept a CBU for storage and Registry listing, the total CBU nucleated cell
count must be 4x107 - 750x107 at start of processing and 12x107 - 750x107 frozen.
Cord blood can be collected from the placenta either while the placenta is still in utero
after the cord is clamped and cut and the baby is removed from the area, or after the
placenta has been delivered, referred to as ex utero. Most in utero collections occur in a
closed system using blood collection bags to minimize the risk of contamination.
In ex utero collections, the cord blood is collected after the placenta has been delivered
and has been moved to a location outside the delivery room. To collect the blood, the
surface of the umbilical cord is disinfected and the umbilical vein is punctured. The blood
can be collected by gravity drainage into a prepared blood bag or it can be drawn into a
60 cc syringe containing an anticoagulant. The collection can be completed within 10
minutes (4). A delay of more than 10-15 minutes could result in a decreased volume of
cord blood and a decreased number of hematopoietic cells .
Processing and Storing Cord Blood Units
The CBU is often not processed immediately after collection because of the unpredictable
timing of deliveries and because the CBUs must be transported to the laboratory for
processing. Current guidelines suggest the CBU be processed within 24 hours after
collection. The processing of the CBU includes the testing described below for quality
control and often includes removing red blood cells and plasma to reduce the volume of
the stored CBU.
Processed CBUs are stored in plastic or vinyl bags and cryopreserved in a liquid nitrogen
(vapor or liquid phase) storage freezer. One study has shown no significant loss of cell
viability in CBUs stored for up to ten years .
Screening
To ensure that CBUs accepted by a cord blood bank are safe and effective for
transplantation, the following evaluations are made:



Review of a maternal and family health history
Laboratory testing of mother's blood sample for infectious diseases
Laboratory testing of the CBU for quality control, including the followings
o Alpha and beta thalassemia screening (DNA)
o Common genetic disorders in Thai population
o Infectious screening accordig to AABB standard
The goal of the maternal health history is to assess family medical history and maternal
risk factors to identify risks for the CBU to transmit genetic or infectious diseases such as
cancer, leukemia, immune disorders, neurological disorders, hepatitis or AIDS. Any
responses that indicate potential risks must be evaluated to determine the suitability of
storing the CBU. In some cases the CBU will be deferred. In others, the CBU may be
stored with information indicating the potential risks noted in the NMDP Registry record
for the CBU. This information is then communicated to any transplant physician and
patient considering the CBU so that the risks can be weighed in the decision to proceed to
transplant.
Cord blood donations are rigorously screened and tested much the same way donations of
whole blood are. However, just as donated whole blood cannot be guaranteed 100% free
of infectious diseases, the risk of the CBU transmitting an infectious disease to a recipient
cannot be completely eliminated.
Tests for infectious diseases carried out on the maternal blood sample generally include:
 Human immunodeficiency virus 1 and 2 (HIV-1, HIV-2)
 Hepatitis B virus
 Hepatitis C virus
 Cytomegalovirus
 Syphilis
Samples from the CBU are tested to assure quality and provide the data necessary for
listing on Siriraj Registry. Testing of the CBU includes:



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Volume of the CBU prior to processing and volume of additives at processing
Bacterial and fungal cultures
ABO blood group and Rh type
HLA type (DNA high resolution)
Nucleated cell and CD34 counts
RESEARCH
Registries/Cord Blood Banks as Repositories of Extensive HLA Data
As large repositories of HLA and often clinical data, registries/banks
should have the resources to analyze this information to direct registry
recruitment (e.g., evaluate HLA diversity to serve searching patients), to
refine search and matching algorithms, to create search tools, and to define
matching requirements for optimal outcome. Access to expertise
in informatics, population genetics, and histocompatibility is essential
to capitalize on this wealth of information.
The Budget and Financial Plan
( see details in Appendix A)
The Outcome and KPI
1. By the year 2006, an international standard UCB banking will be established at
Siriraj Hospital.
2. Expected number of public cord blood storage at this site would be
 500 by the year 2006
 1500 by the year 2007
 3000 by the year 2008
 10,000 by the year 2015
3. The UCB registry established at Siriraj Hospital will join the networking
 National networking by the year 2006
 International Networking by the year 2010
4. The average likelihood of finding a potential unrelated HLA-matched donor for
the Thai increased from 0.003 % (year 2005) to at least
 10 % by the year 2008
 25 % by the year 2015
Bibliography
1. American Academy of Pediatrics; Work group on cord blood banking. Cord blood
banking for potential future transplantation: Subject review. Pediatrics,
1999;104(1):116-8.
2. Gluckman E, Locatelli F. Umbilical cord blood transplants. Curr Opin Hematol,
2000; 7(6): 353-7.
3. Laughlin MJ, Barker J, Bambach B, et al. Hematopoietic engraftment and
survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl
J Med, 2001; 344(24): 1815-22.
4. McCullough J, Clay M, Wagner JE. Cord blood stem cells. In Ball ED, Lister J,
Law P, editors: Hematopoietic Stem Cell Therapy. Philadelphia: Churchill
Livingstone, 2000: 287-297.
5. Mills SB, Appel B. Umbilical cord blood transplantation. In Buchsel PC,
Kapustay PM, editors: Stem Cell Transplantation: A Clinical Textbook. Pittsburg:
Oncology Nursing Society, 2000: 10.3-10.12.
6. Mogul MJ. Unrelated cord blood transplantation vs matched unrelated donor bone
marrow transplantation: the risks and benefits of each choice. Bone Marrow
Transplant, 2000; 25(Suppl 2): S58-60.
7. Rubinstein P, Carrier C, Scaradavou A, et al. Outcomes among 562 recipients of
placental-blood transplants from unrelated donors. N Eng J Med, 1998; 339(22):
1565-77.
8. Sirchia G, Rebulla P. Placental/umbilical cord blood transplantation.
Haematologica, 1999; 84(8): 738-47.
9. Sugarman J, Kaalund V, Kodish E, et al. Ethical issues in umbilical cord blood
banking. Working Group on Ethical Issues in Umbilical Cord Blood Banking.
JAMA, 1997; 278(11): 938-43.
10. Surbek DV and Holzdreve W. Fetal cells from cord blood as stem cell source:
current status and possible implications in gynaecologic oncology. Eur. J. Gynaec.
Oncol., 2001; 22(1): 6-12.
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