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Licensing of cord blood collection comes into force in UK

07 July 2008

By Dr Karen Devine

Appeared in BioNews 465

This week saw the introduction of licensing agreements for UK premises that wish to undertake the collection of umbilical cord blood (UCB) stem cells on behalf of pregnant women. Cord blood has been collected and used in the treatment of certain blood diseases such as leukaemia, and may in the future be used in gene therapy and regenerative medicine. Implementing the European Tissue and Cells Directive, which was transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulation in 2007, the Human Tissue Authority (HTA) now permits only licence holders to collect cord blood for either public or private use. This legal requirement became effective on 5 July 2008 and is the first time that the collection of cord blood has been regulated within the UK.

Under the new regulations, only specialist personnel that are trained to procure units of the highest quality on premises that meet essential standards - typically maternity units - may collect the cells. In addition, those who operate under the licence must demonstrate best practice to ensure that the third stage of labour will not be compromised in favour of collection. Furthermore, they must operate within a system that allows the collected cells to be traced for identification and monitoring purposes. Such stringent controls, the HTA says, prioritise the safety of mother and baby during collection, which takes places in the third stage of labour, a period when essential checks and observations are carried out. The requirement for only qualified staff to collect UCB also ensures that possible contamination of the cells is at a minimum.

In a press release, Sandy Mather, the Director of Regulations at the HTA said: 'We have been measured and proportionate in the way that we have implemented this regulation. We aim to put patient safety first, while making it as simple as possible for professionals to become compliant with the new rules'. The HTA has been keen to provide help and advice to anyone making an application for a licence and has already guided many professionals through the process.

SOURCES & REFERENCES
HTA | 05 July 2008
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

06 April 2009 - by Sarah Pritchard 
Some UK National Health Service (NHS) hospitals are banning the collection of umbilical cord blood at birth unless it goes into a public blood bank rather than being stored for future use by the individual. King's College hospital in London and Watford General hospital in Hertfordshire have...
15 September 2008 - by Dr Karen Devine 
The UK's Antony Nolan Bone Marrow Trust this week launched a new initiative - the Antony Nolan Cord Blood Bank and a combined stem cell research centre at Nottingham Trent University. Mothers who deliver babies at the Kings College Hospital, London, are being recruited to donate the stem...

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The UK's Human Tissue Authority (HTA) has announced that the collection of umbilical cord blood stem cells is to be regulated for the first time in the UK. Cord blood contains a rich source of stem cells that could be used to fight disease and may in...
06 May 2008 - by Dr Karen Devine 
In the 21st Century, the collection and use of stem cells from umbilical cord blood (UCB) is anything but a new phenomenon. Since the first successful UCB transplant in 1988, the use of UCB for transplantation purposes has been used in over 6,000 treatments worldwide and has proved to be...
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Once again, umbilical cord blood (UCB) stem cell collection and storage has been in the headlines of the popular press. UCB can be collected at birth and stored for the future use of the donor, its siblings or donated for public use. There are two main types of banking - public...
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