Guidelines for the collection of Stem Cells

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1 Guidelines for the collection of Stem Cells INITIATED BY: APPROVED BY: Ruth Friel, Senior Midwife Integrated Business, Obstetrics, Gynaecology, Sexual Health & Quality And Safety Group DATE APPROVED: 18 th February 2016 VERSION: Two OPERATIONAL DATE: 22 nd February 2016 DATE FOR REVIEW: 3 Years From Date Of Approval Or If Any relevant Legislative Or Operational Changes DISTRIBUTION: All Midwifery and Obstetric Staff via Sharepoint FREEDOM OF INFORMATION STATUS: Open 1

2 Guidelines Definition Clinical guidelines are systemically developed statements that assist clinicians and patients in making decisions about appropriate treatments for specific conditions. They allow deviation from a prescribed pathway according to the individual circumstances and where reasons can be clearly demonstrated and documented. Minor Amendments If a minor change is required to the document, which does not require a full review please identify the change below and update the version number. Type of change Why change made Page number Date of change Version 1 to 1.1 Name of responsible person Equality Impact Assessment Statement This Procedure has been subject to a full equality assessment and no impact has been identified. Contents Definition..3 Rationale..3 Commercial Blood Collection..4 Procedure References.. 4 Appendix One; Admission of Liability 5 2

3 Definition Cord blood is the baby s blood that remains in the placenta and umbilical cord after birth. It contains stem cells which can be used for transplants in children and young adults. This is known as a stem cell transplant and may be used in the treatment of many diseases including immune, blood and metabolic diseases. The Royal College of Midwives (RCM) and Royal College of Obstetricians and Gynaecologists (RCOG) believe there is insufficient evidence to recommend routine private collection and storage of cord blood for this purpose (RCOG 2011). Rationale In the event of a woman requesting this procedure, a senior midwifery manager must be informed to ensure the company being used has a current Human Tissue Act (HTA) licence for the procurement and storage of stem cells. The woman should be made aware that the midwife/ doctor will not assist in the collection of cord blood for the purpose of stem cell collection and will not be held responsible for the sample. All midwives should familiarise themselves with the evidence and issues around stem cell harvesting so that they can discuss these with women as appropriate. If a woman requests stem cell collection it is imperative that the collection should not in any way compromise the birth process, or any procedures necessary for the safety of mum and baby. The collection of cord blood should take place after safe delivery of the placenta, away from the delivery room (or theatre) by a person not involved in the birth (RCM 2007, RCOG 2008). A skilled technician acting in behalf of the commercial company providing the service will take the cord blood. The company must provide evidence of possession of a HTA licence. If the company does not have a HTA licence, the procedure cannot be allowed. Some families are at particular risk from rare genetic disorders. If there is a known genetic condition or there is already a child with a blood related disorder, such a leukaemia, in the family, clinicians may decide to recommend stem cell collection. Collection of cord blood for these at risk families is available through public sector cord blood banks and is recommended by the RCOG (2006). Arrangements can only be made through the NHS cord blood bank, currently only available in England. 3

4 Commercial Blood Collection It is important to distinguish between medically indicated cord blood collection and the practice of commercial cord blood collection for stem cell harvesting and storage, which is attracting interest from parents in the UK. There is still insufficient evidence to recommend commercial cord blood collection and stem cell collection in low risk families (RCOG 2008). Procedure If any woman is requesting this procedure, a senior midwifery manager must be informed who will ensure all information is provided as necessary. Any woman requesting cord blood collection should be made aware of this guideline and where to obtain further information. Cwm Taf UHB cannot recommend a provider of this service. A disclaimer must be completed in the antenatal period by the mother, before the sample is collected (see appendix one). The commercial company must provide evidence of an HTA licence prior to collection. They must also provide a skilled technician to undertake the collection procedure, to be arranged with and agreed by a senior midwifery manager. Patients considered to be at high risk of genetic blood disorders may have storage through an established public sector cord blood bank, as arranged by an obstetrician. There should be no change in the usual or planned management of the third stage of labour. The service may not be carried out in all cases, such as where the attending clinician believes it to be contraindicated. This will include; all premature births, nuchal cord, or maternal haemorrhage (at clinician s discretion). Records should be maintained in accordance with Cwm Taf UHB and NMC record keeping guidelines. References RCOG (2206) Advice on Umbilical Cord Blood Banking and Storage RCM (2002, 2007) Position Statement on Commercial Cord Blood Collection RCOG (2008) Statement on the New Human Tissue Act rules for cord blood collection 4

5 Appendix One Admission of Liability - Cord Blood for Stem Cell Collection Cwm Taf University Health Board (CTUHB) accepts no responsibility for the collection, storage and transportation of cord blood for stem cell storage. You are responsible for cord blood collection, storage and transportation of the sample. Staff within the CTUHB are not responsible for obtaining, storing or transporting the sample. Cwm Taf University Health Board will not be liable for any damage caused to the stem cells. I of Acknowledge the above, and agree that I shall make no claim on Cwm Taf University Health Board if the sample is unobtainable, insufficient, or in any other failure to obtain the sample. Signed.. Date.. 5

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