Intended for healthcare professionals

Rapid response to:

This Week In The Bmj

Commercial cord blood banking: should we encourage it?

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7572.0-d (Published 12 October 2006) Cite this as: BMJ 2006;333:0-d

Rapid Response:

NHS maternity units should keep an open mind on the commercial banking of umbilical cord blood

A recent article in the BMJ by Leroy Edozian (BMJ 2006;333:801-4)
argues that NHS trusts should not encourage commercial banking of
umbilical cord blood. This thought provoking article sets the scene
perfectly for further debate and the time is right to present a coherent
point of view from the commercial perspective to bring the whole subject
into the open for honest, open and transparent debate. Cord blood stem
cells are a precious resource and it is our duty to ensure that they are
utilised appropriately and effectively.

Firstly let us dismiss the myth that cord blood processing and
storage is ‘insurance’ biological or otherwise. Cord blood processing and
storage is a biomedical process which provides stem cells for future
transplantation which could, in the correct situation, save a life. The
principle of insurance is that if a problem arises then that problem is
compensated by money. The ‘compensation’ in the case of cord blood
processing and storage is the potential to save a life using stem cell
technology. To confuse cord blood processing and storage with insurance is
misleading and only emphasizes the monetary aspect the technology, not the
potential medical benefits. Secondly cord blood processing and storage is
carried out with the primary intention of the stem cells being available
for use throughout the family, not simply for use by the baby alone.

Growth of blood banking

Umbilical cord blood stem cells are now fully established as a source
of stem cells for transplant into both adults and children for a range of
blood disorders and metabolic diseases. This acceptance has resulted from
the activities of both the public and the private sector which has
resulted in over 6000 cord blood stem cell transplants worldwide to date.

There is indeed considerable scientific, political and media hype in
the field of stem cell biology not least in the area of embryonic stem
cells where minor advances of little clinical significance often result in
‘front page’ news. In contrast the achievements of stem cell biologists
working on cord blood and adult stem cells are rarely reported or debated
by anyone. Cord blood stem cells have been shown to have enormous
potential to create a range of tissues but these observations are still
very much in the research laboratory. There are ongoing clinical trials,
such as the one I am Scientific Advisor to in Canada using cord blood stem
cells to treat multiple sclerosis. This is a double blind, placebo
controlled clinical trial in which we hope will shed more light on the
true potential of cord blood stem cells.

Marketing tactics by commercial cord blood banks, both in the past
and to some extent still today, have at best been misleading. It is
absolutely essential that the industry should unite in a campaign of
honesty and transparency and anyone unwilling to be involved in this
should leave the industry or be labeled as unreliable and untrustworthy by
the rest of the industry and regulatory bodies.

Public and commercial banking

The NHS has indeed had a Public Cord Blood Service, which is part of
the NHS Transfusion Service, since 1996. The service provided is of the
highest quality but is limited in its’ scope and as a result many valuable
cord blood units in the UK are still discarded.

Commercial cord blood services should be working in collaboration
with the public sector to provide a more wide-ranging cord blood service.
My own experience is to develop a public cord blood service to run in
parallel to, and partly funded by, the private service. I was instrumental
in developing such a service in Toronto, Canada where the Victoria Angel
Registry of Hope (a public cord blood service) no runs in parallel to the
commercial company Cells for Life. This kind of model, or very similar, is
what we should all be debating and working towards in the UK. It is our
intention at UKCBB to develop such a model and we actively invite the
participation of the NHS and the public cord blood banks to ensure the
optimisation of the service.

Scientific argument

The advantages of both public and private cord blood storage are very
real and have been clearly demonstrated over the past few years. There are
still many unanswered questions on the scientific side and as a stem cell
biologist this is perhaps the most exciting aspect of cord blood stem cell
technology. There are often ‘scientific objections’ raised to private
storage of cord blood and instead of being put forward as arguments
against private storage these should be clearly stated and understood by
everyone involved. The major points are:

• An acceptance of the likelihood of family use use of a cord blood
unit. This ranges from 1:1400 to 1:20000 and as long as this rate of usage
is understood and accepted by everyone involved then this can hardly be
cited as an objection. It is simply an accepted risk as are most things in
life.

• Autologous stem cells, and indeed bone marrow, are alternative
sources of stem cells to cord blood and this must be made very clear by
all cord blood companies. Nevertheless, autologous stem cells and bone
marrow are not always possible to use for example in a young child or in
the elderly.

• Pre-leukaemic mutations may occur in utero and these may be carried
in the cord blood. At present there are insufficient data to confirm the
significance of this observation either way and once again honesty and
transparency must be foremost so that everyone can understand the
potential limitations if these observations are confirmed in the future.
It is of course possible that we all carry these pre-leukaemic mutations
and very likely that further specific mutations and environmental events
are needed to develop leukaemia.

• Public cord blood services and bone marrow banks are indeed an
important source of stem cells and this must be recognized and encouraged
by everyone involved. This is central to the debate I am trying to start
on public/private collaboration.

• There is speculation about the future use of cord blood stem cells.
This must be kept to an absolute minimum and guided by the current
research in the field. Excessive hype of cord blood stem cell technology
must be controlled by the regulatory authorities.

Risk Management Issues

Commercial cord blood collection, processing and storage may or may
not present risk to those involved. These risks, if present, can easily be
minimized or removed by collaboration and openness. Some basic guidelines
should be debated and implemented in order to create a gold standard,
these include:

• The routine collection of cord blood, from the placenta after the
delivery of the placenta, by an independent technician/nurse is critical.
This is the current protocol of the NHS public cord blood bank and must be
applied in all contexts. If carried out properly this process takes the
cord blood collection away from the mother and baby and therefore cannot
in any way interfere the care of the mother and baby. Technology also
exists for the flushing of the placenta after initial cord blood
collection to optimize the number of stem cells collected. This should be
introduced as routine to optimise stem cell numbers and therefore extend
the clinical usability of cord blood units.

• Delivery unit staff must not be involved in cord blood collection.
Cord blood collection staff will either be independent, fully trained
nurses employed by the private cord blood patients or collection staff
employed by the private cord blood banks. These staff will be fully
trained to the satisfaction and acceptance of the NHS trusts.

• Cord blood gas analysis must be carried out prior to handing the
delivered placenta to the collection technician. It must be made clear
that parents do not have any input into the prioritization of cord blood
gas analysis and cord blood collection. This is a medical decision to be
made by medical staff on behalf of the patients.

• All consent, translation services and paperwork will be the
responsibility of the cord blood technician/nurse and the cord blood
company itself.

• Cord blood collection at multiple and pre-term delivery will be
entirely at the discretion of the medical staff involved. Labelling errors
will be minimized in multiple births by the use of a dedicated cord blood
collection technician/nurse.

• If there is a medical indication for delayed cord clamping, e.g.
pre-term babies, then this procedure will be utilized at the discretion of
the medical staff.

• Infectious disease screening and medical history procurement is the
responsibility of the private cord blood bank.

• Cord blood banks in the UK must operate under a Human Tissue
Authority (HTA) license which ensures compliance with the European Tissues
and Cells Directive. This is now a legal requirement in the UK and ensures
quality of service from all private cord blood banks. This is a welcome
and necessary piece of legislation. The collection of cord blood within a
delivery unit by trained staff meets the requirements of the HTA.

These and other points must be openly debated to develop a Code of
Practice for cord blood collection and storage which meets the needs of
everyone involved. Private cord blood banks, public cord blood banks, the
HTA, the RCOG and NHS trusts must meet to begin to develop a collaborative
process to achieve these goals.

Medicolegal issues

It must be understood by cord blood clients, the medical profession
and NHS trusts that all indemnity regarding cord blood collection lies
with the cord blood bank as described in the cord blood collection and
storage agreement. Cord blood collection is not part of routine NHS care
and the NHS is not obliged to train staff for the cord blood industry.

The cord blood itself remains the property of the parents until the
child reaches the legal age of consent at which point ownership transfers
to the child as described in the cord blood contract. There are therefore
no property issues or potential law suits lying in wait.

There is a US patent, by a company called Pharmastem, on cord blood
collection. This patent does not extend into Europe and its’ validity in
the USA is currently under question.

Ethical considerations

Medical paternalism must be avoided in the context of cord blood
collection. Parents must make informed decisions based on the evidence not
the hype. Parents to be are indeed vulnerable and it is the duty of care
of the cord blood companies to provide unbiased, unemotional information
and to avoid any possibility for ‘emotional blackmail’. It is the role of
the regulatory authorities such as the HTA to ensure that cord blood
companies operate in an ethical manner and that transparency and honesty
are foremost. Once again a clear Code of Practice must be developed to
ensure that ethical guidelines are met by all cord blood companies.

Public policy perspective

Constraining commercial cord blood banking in the UK may inhibit
innovation in cord blood stem cell technology but encouraging
public/private cord blood collection, with open and clear codes of
practice as described above, will enhance the technology. The work of
existing public cord blood banks will not be undermined but enhanced with
increased numbers of public cord blood units made available for
transplant. If a cord blood donor needs a donated unit and it is still
available then it will happily be handed back to the donor for their own
use. Cord blood stem cell related research will progress more rapidly
bringing many benefits to many diverse patients around the World.

Conclusion

NHS trusts must not fear cord blood collection or back away from
debate. Reputable commercial cord blood banks are keen to debate the
issues with all interested parties, to reach an agreed code of practice
and to take the technology forward both in the public and private arena.
Risk management, medico-legal, ethical and public policy concerns can be
met and overcome and a truly efficient and effective public and private
cord blood service developed. The provision of open and clear information
for parents and true collaboration between NHS trusts and the private
sector cord blood banks will resolve this long standing debate once and
for all.

Competing interests:
Dr Hollands is the Chief Scientific Officer of UK Cord Blood bank

Competing interests: No competing interests

13 October 2006
Peter Hollands
Chief Scientific Officer
1, Harley St, London, W1G 9QD