Submitted by Dr Peter Hollands, Oct 31, 2006 04:31

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 in the UK 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

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.

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