Stem cells and cord blood
Human stem cells and cord blood (which is rich in stem cells) are used to research the causes of and treatments for illnesses. Through this research, stem cells can be used for patient treatment.
Human stem cells can be used for the treatment of cancer, diseases of the blood such as leukaemia, and have the potential in the future to treat disorders of the brain and nervous system such as Parkinson's disease.
The HTA licenses establishments which remove, store, test, process, use or distribute human cells that will be used to treat patients. This includes the use of cell lines grown outside the human body for patient treatment. More information about cell lines can be found in our FAQs about the regulation of stem cell lines (see the link on the left of this page).
The UK Stem Cell Toolkit is a single resource for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. The Toolkit consolidates existing regulatory resources and helps to clarify where the remit of individual regulators begin and end.
The Toolkit has been developed with the support of the Gene Therapy Advisory Committee, and regulators including the HTA and MHRA. It demonstrates the commitment of regulators, government and funders to work together to help stem cell scientists in the UK translate basic stem cell research into clinical outcomes and commercial benefits.
Umbilical cord blood may be collected at the time of birth and stored, so that it is available for potential future treatment of the child or another person.
Since 5 July 2008, any person collecting cord blood must be acting under the authority of an HTA licence; or where appropriate, a third party agreement (TPA) with an HTA-licensed establishment. In addition, those collecting cord blood must be appropriately trained to ensure the collection takes place safely, and that the sample is not contaminated and is safe to use
The HTA has produced a guidance document for establishments which it licenses to undertake activities related to the procurement, testing, processing, storage, distribution, import and export of umbilical cord blood cells (you can download a copy of this document on the left side of this page). This document will raise awareness of how the legislation relates to these establishments and provide advice on areas which are specific to cord blood and related tissues.
The HTA does not regulate or provide advice about the effectiveness of treatments using cord blood.
There are a number of important messages about the regulation of cord blood collection (you can download a flyer of these messages on the left of this page):
SAFETY: HTA regulation ensures that the cord blood is collected in a way that minimises the risk to mother and child. This is why collection must be carried out by a properly trained professional and on appropriate premises.
QUALITY: HTA regulation ensures that the best quality samples are taken. It also means that samples are traceable; so should there be a problem the cells can be traced to other batches.
CONSENT: HTA regulation means consent must be given by the mother for cord blood to be taken. Risks, benefits and options must be explained to the parents so that informed consent can be given.
LAWFUL: Activities involving the collection, testing, processing, storage, distribution or import / export of cord blood must take place under the authority of an HTA licence or where appropriate, a third party agreement with an HTA-licensed establishment.
Parents considering public or private cord blood banking should discuss the practicalities of collection at an early stage of pregnancy. If they decide to go ahead, parents should make sure that appropriate arrangements are in place for the lawful collection of the cord blood by an appropriately trained person. Where the hospital does not hold an HTA licence it may be possible to get a trained specialist to carry out the collection (under a third party agreement with an HTA-licensed establishment). However, this usually needs to be organised well in advance of the birth.
Although the primary responsibility for compliance with HTA requirements lies with licensed establishments (and organisations acting on their behalf), parents should ensure they are familiar with the legal requirements and do not act outside of the law, for example request an unauthorised midwife or birthing partner to undertake the collection. Cord blood collection, like any medical procedure, is not risk-free and it is essential that only trained, authorised personnel carry out the collection.
Licensed establishments are required to report all instances of unlawful cord blood collection to the HTA. The HTA can require the disposal of any unlawfully collected cord blood and may decide this is necessary in certain circumstances.
Please use the links on the left of this page to access more information about stem cells and cord blood.
Updated November 2010