Lecture, leuven; november 2013

Cord Blood Banks between Therapy and Research:
Ownership, Informed Consent and Solidarity
Elena Salvaterra, PhD
msalvaterra@bp.lnf.it

Aims
• Give a picture of cord blood and cord blood
banks
• Identify ethical principles and issues related to
cord blood banks
• Look at the interaction of science, technique
and ethics in cord blood banking
• Discuss the ELSI of cord blood banks
Erasmus Mundus Students -Leuven 2013 2

Cord Blood….Banks

… From the Newborn Cord Blood …

… To Cord Blood Banks…

Preliminary Questions
• Why is newborn
cord blood
important?
• Why should we
collect and store it?
• How is the newborn
cord blood linked to
cord blood banks?

… Newborn Cord Blood from Waste Material ..
In the past,
newborn cord
blood was
usually destined
to incinerators

…to Source for Transplantations and Research…
• Since the 1988, CB
life completely
changed
• Proven standardised
treatment for a
number of diseases
and pretious source
of stem cells
suitable for research

Newborn Cord Blood History (1)
• The first CB
transplant was
performed in a 5-year
old child with Fanconi
Anemia (1988)
• It was a related CBT
using the CB stem
cells derived from the
UC of the child sister

Newborn Cord Blood History (2)
• In 1991, the first public cord blood bank was
established at the New York Blood Center
• In 1993 the first allogenic unrelated CB
transplant performed in a 4-year old child with
laukaemia
• Since then, cord blood (CB) has been recognised
standard practice treatment option in pediatric
allogenic transplantation and a promising
treatment in adults

Cord Blood Characteristics and Uses (1)
• Like Bone Marrow (BM) and Perhiperhal Blood (PB), cord
blood is rich of stem cells
• Stem Cells: «undifferentiated blank cells» (Fossett, 2009)
able to produce either cells like themselves (self-renewal)
or cells of one or several specific differentiated types

• CB is rich of hematopoietic stem cells that can be
used for the treatment of hereditary and/or
haematological conditions, both malignant and non-
malignant such as:
– Laukaemia
– Lymphoma
– Myeloma
– Selected Solid Tumours (e.g., retinoblastoma)
• Hematopoietic Stem Cells: Blood Forming

• CB is rich of non hematopoietic stem cells whose
potential is associated with future tissue repair
and regeneration (neural, cardiac, epithelial,
hepatocytic, and dermal tissue)
• Non hematopoietic stem cells: include
mesenchymal stem/stromal cells (MSC),
endothelial progenitor cells (EPC), and induced
pluripotent stem cells (iPSC)

Cord Blood
«Ethically-Free» Stem Cell Source
• Stem cells cointained
in the umbilical cord
blood are adult stem
cells
• Younger than stem
cells included in BM
and PB
• Older than stem cells
derived from human
embryos

Cord Blood Advantages
and Disadvantages
Compared to BMT and PBT, CBT Advantages
• Absence of risks to donors (mother and newborn)
• Reduced risk of transmitting infections
• Greater histocompatibility/more access to patients
• Immediate availability of cryopreserved cells
Disadvantages
• Longer patient recovery

Cord Blood Banks and Transplants Worldwide
Public Vs Private (1)
• Since the first CB transplant in 1988, more
than 20,000 allogenic CB transplantations
have been performed worldwide
• More than 600,000 cord blood units stored in
public cord blood banks
• A number of international networks created (Netcord,
Asiacord, Bone Marrow Donors Worldwide) and registries
listing publicly banked CB units developed (Eurocord, Center
for International Blood and Marrow Transplant Research)

More than 100 public CB Banks created, mainly
based in Australia, United Kingdom, USA,
Belgium, Spain, Italy, France, Brasil, Israel

• Over the last 15 years, 900,000 cord blood units
have been stored in private banks for personal
use
• About 100 autologous transplants have been
performed worldwide
• There are about 200 private cord blood banks
worldwide
(www.parentsguidecordblood.org)

• Based on the Eurocord Registry, about 600
patients have been transplanted with allogenic
related CB from 1988 to 2010 (family CB
tranplants)
• Most recipients were children
• Treated diseases were mostly non malignant
(e.g.,hemoglibonopathies, thalassemia)
• In contrast to unrelated cord blood transplants,
the number of family CBTs has not increased year
after year

What Are Cord Blood Banks? (1)
• Biobanks providing services of collection,
processing, storage and distribution of CB units for
transplantation and research
• According to the origin of the collected source, CB
banks fall into the broader category of pediatric
biobanks
• CB banks represent a special model of pediatric
biobank because of they provide CB units for clinical
applications (transplants) and research
• Based on financial support, CB banks also represent a
relevant model for public, private or hybrid biobanks

• Based on:
financial support
technical aspects
offered services
underlying values

• three broad categories of cord blood banks can be now
identified:
Public
Private
Hybrid

Public Cord Blood Banks (1)

• Publicly funded (no fee for service)
• Usually accreditated services of
collection, processing, storage, controls
and distribution of CB units (AABB,
Netcord, Asiacord…..)
• Structured process of information and
consent

• Dedicated to allogenic transplantation including:
Related CB transplantation (sibling and relatives)
Unrelated CB transplantation (all patients needed
a CBT worldwide)
• Allogenic CBTs are recognised a standard practice
treatment option in pediatric allogenic
transplantation, increasing in adult treatment
• Promote values as altruism, solidarity, justice
→relationships of solidarity

Private Cord Blood Banks (1)
• Fee for service
(from 1000 to
2000 Euros per
year + annual
fee for the
storage)
• CB units are stored for
autologous or family
(related) use

• Private CB banks for
autologus use are not
supported from clinical
evidence based data
• In spite of the large
number of stored CB
units  only three
published reports of
autologous CBTs
• Often they provide
misleading information to
parents

• Chance that the CB stored privately will be used
for autoloogus transplant is very low
• Although clinical trials are presently underway,
regenerative medicine remains little more than
a promising possibility and the value of CB in
this field is also uncertain
• Benefits advertised from private CBBs are
largely speculative

• Private CBBs promote the private storage of
the newborn CB as a «biological insurance»
• Private CBBs appeal to the sense of obligation
of parents to store the newborn CB privately
• Often private CBBs sell false promises
• Commercial relationship model

• Make a distinction between:
 private CBBs for autologous use only (like
in Australia) or in addition to related use
and
 private CBBs for allogenic related (sibling
or relative) transplantation (family CB
banks)
and

• Family CBB services are clinically indicated and
validated in families where the pregnant mother:
 has an existing child or
 has a known risk to have a child
affected by a disease treatable by related UC
trasplantation
• Family CBBs, like private CBBs in general, require
a fee for service ($ 1,500 for unit and $ 50 for
storage)

Hybrid Cord Blood Banks (1)
Fall into two broad categories:
• Many offer both public and private services
• So far, the only public bank offering both the
services is the Alberta Cord Blood Bank in
Canada
• Other collect and store CB for private
autologous or related use but make available
the stored CB units to the public system,
based on the choice of parents

Other Paradigms
• Turkish Model: according to the government
legislation, 25% of all privately stored CBUs is
donated to the public system
• Virgin Model: 80% of the CBUs are donated to
the public system and 20% is stored for private
use. Profits are used to fund stem cell
research

• Spanish Model: CBUs privately stored are
recorded on the Official Spanish Register of
Bone Marrow Donors.
• Should a patient in need of a transplant find a
matched donor, parents are obliged to donate
the cord blood and the storage fee is
reimbursed

Cord Blood Banks
ELSI

Cord Blood Banking and Use
ELSI Overview (1)
• Cord blood banking process and use raise a
number of ethical, legal and social issues
Public CBBs are expression of:
• Altruism
• Solidarity
• Cooperation
• Justice as fair allocation of available CB units

ELSI Overview (2)
Private CBBs are expression of:
• Competition
• Speculation
• Profit markets
• Conflict with the principle of justice
• Conflict with a model of social/individual trust
in science and technology

ELSI Overview (3)
Hybrid CBBs are expression of a combination of
values underlying public and private CBBs
• Autonomy
• Solidarity
• Justice
• Profit
• “Solidarity market” Vs “Profit market”

Special ELSI
• Ownership
• Informed consent
• Solidarity
• With regard to ownership and informed
consent CBBs are a relevant model for ELSI of
pediatric biobanks in general
• Solidarity is a basic principle of pediatric
biobanks for research aims

Ownership (1)
• Ownerhsip of body and body parts remains widely
controversial either in common and continental legal
system
• Personality Right Teory:
 The body and its parts are considered as corporeal components
of the personal identity
 Self-autonomy plays a crucial role
• Property Right Teory
 Body parts are considered as things which can be bought and
sold on a market place

Ownership (2)
Within the realm of cord blood banks:
• Owner of the cord blood and the cord itself is
the newborn
• The mother/parents is/are legitimate to
exercise autonomy rights on behalf of the
newborn until the age of the maturity

Informed Consent
General Issues (1)
• Informed consent for cord blood banking is
expression of the broader issue of informed
consent for pediatric biobanks
• Pediatric biobanks raise the issue to identify
the subject legitimate to give the informed
consent: parents/legal representative or child?
• Cord blood banks adds a third option to the
model of pediatric biobanks: mother, parents
or child?

Informed Consent
General Issues (2)
• According to the prevailing ethical and
legal position, the informed consent for
cord blood collection and banking should
be given by the newborn mother
• The informed consent of both parents is
not legally necessary

Informed Consent
General Issues (3)
• The child has the right to decide on the
disposition of the stored cord blood (where
available) once he/she becomes competent
• The age for reaching to capacity to make
autonomous decisions (including informed
consent) is very controversial in cord blood and
broadly pediatric biobanks
• The mother informed consent principle is
different from the both parents informed consent
rule which is generally followed in pediatric
biobanks

Informed Consent
Special Challanges (1)
The double faces of the timing
• Timing of the maternal consent provision
• Timing of the cord blood clamping

Informed Consent
• Working Group on ethical issues in umbilical
cord blood banking and the American
Academy of Pediatrics consider intrapartum
and after-collection consent unethical
• They recommend written informed consent be
obtained during prenatal care, before the
onset of labor
• A confirmation of consent after delivery

Informed Consent
…..Cord clamping timing………
• Although there is no a scientific consensus on the
best time to clamping the newborn cord, it is known
that clamping early allows to have the largest volume
of neonatal blood, without serious effects on the
newborn health (apart from pre-term infants)
• Timing of the cord clamping and risks/benefits
associated with early or delayed clamping should be
clarified in the informed consent process

Informed Consent Content (1)
• Expectant mothers should be given clear and
appropriate information about the options to
donate cord blood for public or private or
mixed use
• Expectant mothers should be informed on
procedures for collecting, processing, testing,
storing and using the cord blood and related
risks and benefits

• European Group on Ethics in Science and New
Technologies – Opinion on “Ethical aspects of
umbilical cord blood banking”, 2004
• European Recommendation Rec (2004) 8 of
the Committee of Ministers on Autologous
cord blood banks, 2004

EGE Opinion
“If the cord blood is to be stored by a private bank,
appropriate information should be given to the
consumers (…) including the fact that the likelihood
that the sample may be used to treat one’child is
currently negligible, that the future therapeutic
possibilities are of a very hypothetical nature and
that up until now there is no indication that the
present research will lead to specific therapeutic
applications of one’s own cord blood cells. This
information should be made clear on all media (…)”

European Recommendation
“Where autologous cord blood banks are being
established, the promotional material or
information provided to families must be
accurate and fully informed consent to cord
blood storage must be obtained”

• The analysis of information of the English
websites of 148 private cord blood banks showed
that “a pattern of confusing and potentially
misleading information” were provided
• Often, private cord blood banks publish lists of
disorders treatable through CB transplans
without a clear distinction between diseases for
whom the CBT is a proven treatment and those
which could be treated in the future

• Private cord blood banks often do not explain
the difference between autologous and
allogenic cord blood transplantation
• They leave expectant parents to suppose that
indications for allogenic transplant also apply
to autologous transplantations

Solidarity and Justice in Cord Blood Banks (1)
• Altruism and solidarity are basic principles of
cord blood banks for allogenic
transplantations
• Altruism and solidarity have different
applications based on their clinical use:
transplantations in sibling or relatives
transplantations in unrelated patients

• Altruism and solidarity meet the value of
justice in public cord blood banks
• By making available CB units for any patient in
need of stem cell CBT worldwide, public cord
blood banks promote the principle of justice
as fair allocation of available resources
• Respects for this principle has relevant
implications for racial and ethnic minorities

• Racial and ethnic minorities are usually
underrepresented on the bone marrow registries
worldwide

• As reported in the literature, although a
matched unrelated donor can be found for up
to 75% of patients of Western European
origin, for many ethnic groups the reverse is
true with no more than 20-30% being
matched
• Public CBBs contribute to overcome this
problem allowing a great number of patients
to benefit from a smaller pool of donors

A Patchwork of Values (1)
• Combination of ethical values surrounding cord
blood banking is not easy to understand in practice
• Public cord blood banks promote values of
autonomy, solidarity and justice through allogenic CB
transplantation
• They permit to a large number of patients to find an
adequate donor worldwide beside the racial and
ethnical differences
• They provide high quality services
• They do not require a fee for service

Patchwork of Values (2)
• Private and many hybrid cbbs support a for profit
approach
• They promote services which are not based on well
proven clinical data
• They provide often inaccurate and potentially
misleading information to expectant parents
• They limit the access to CBT to a number of patients
including racial and ethnic minorities
• They provide expensive services

Conclusion (1)
• Which values (and consequently CBBs) should
be supported?
• Should the parent choices be accepted
regardless of the given information and the
underlying values?
• Is better to give more chance of care to a large
number of patients or to restrict them to a
selected group?

Conclusion (2)
• What is critical in private cord blood banks,
the false hopes they give to expectant parents
or the fee for service they ask for?
• Is ethically acceptable the family cord blood
bank model, asking for a fee for clinically
proven services?
• Which risks are associated with a bio-market
model?

Lecture, leuven; november 2013

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