07 July 2008
ByAppeared 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.