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 the future be used in regenerative medicine. The regulation forms part of the European Union Tissue and Cells Directive, which was transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations in 2007.
As of 5 July 2008, only licensed premises will be allowed to procure cord blood for either public or private use, a move that seeks to ensure the collection process is facilitated by qualified staff trained to collect samples of the highest quality. In addition, those acting under the licence will be required to implement procedures that do not detract attention away from the mother and baby at the time of collection and operate a fully traceable system for any cells they procure for treatment purposes. The licence has been dubbed 'a badge of honour' by the HTA.
The requirement for the collection process to be carried out exclusively by trained professionals places a ban on unqualified parties such as fathers and birth partners from collecting the cells on behalf of the mother, which has been suggested as an option by some private companies who sell collection kits to expectant families. Private companies currently rely on the good will of midwives to collect on their behalf, but they may not have received any formal training for this type of procedure.
The Times newspaper reports that the new regulation has triggered a row between the HTA and Virgin Health Bank (VHB), who operate a public and private banking facility, with VHB declaring that the authority has been hasty in its decision and that thousands of parents would be denied the opportunity to collect their cells. However, Andrew McNeil, Chief Executive of the HTA said, 'We have heard that fathers, who of course have no experience in collecting cord blood, may be involved in the procedure. The result is that the best samples may not be collected'. He added: 'The worry is that if inexperienced people are involved, it will not be done at the right time and in the right way. We are introducing this regulation to make sure that the best quality samples are taken in the safest way'.
The new regulations have been welcomed by the Royal College of Obstetricians and Gynaecologists (RCOG), who in its scientific opinion paper published June 2006 called for greater control of the collection process and management of the third stage of labour. Professor Peter Braude, chair of the RCOG's expert committee on cord blood banking commented that 'we are pleased that the procurement of umbilical cells will now be regulated by the HTA in the pursuit of quality.
