Collecting cord blood to save and improve lives. Rebecca Roberts

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1 Collecting cord blood to save and improve lives Rebecca Roberts

2 Cells4Life Introduction to stem cells Why cord blood is important Legislation Cells4Life Cord blood collection

3 What is a stem cell? Cells that are capable of self renewal Cells that are able to develop into specialized cell types Found in multi-cellular organisms Categorised based on the ability to change as Totipotent Pluripotent multipotent

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5 Stem cells in cord blood Able to form blood cells (1968) Shown to be the same as bone marrow (1978) Used since 1988 if matched to a donor Leukemia first use Other diseases now being treated

6 Stem cell types in cord blood Transplant Medicine - HSCs Haemopoietic Stem Cells (HSCs) Original reason for cord blood collection CD34+ for which Don Thomas 1990 was awarded Nobel Prize Regenerative Medicine - MSCs & VSELs Mesenchymal stem cells (MSCs) Tendons, bone homing of CD34+ cells to bone marrow Osiris clinical trials VSELs (potentially) Cord Blood Derived Embryonic-like stem cells McGuckin et al 2005 University of Louiseville 2007

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8 Importance of cord blood Cord blood is easy to collect especially compared to bone marrow, peripheral blood Cord blood collection presents NO risk to donor 25% chance of a perfect match between siblings Cord blood does not have as many HLA Mis-matches in HLA types are better tolerated If this is not collected, it is thrown away It is a perfect match to the child for life

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10 Regenerative medicine Not just saving lives but helping to live a life Can repair tissue and organs Whiplash Tendon damage Cartilage damage More diseases than leukaemia now being treated Encephala Beta thalassemia Cerebral palsy

11 Clinical trials using cord blood today Diabetes Type 1 Cerebral palsy Cerebral injury Autism Graft versus Host Disease Sickle cell Rheumatism Arthritis

12 Statistics 70 diseases currently being treated Prof Sir Mike Richards in 200 if JUST current treatments stay the same Horrowitz et al in 3 people will use a family banked sample in their lifetime Harris et al 2007 Expert Opinion Biological Therapy Over 250 clinical trials currently using cord blood Over 7800 papers published on the use of cord blood

13 Currently Placenta and cord blood is thrown away without reference to parents Ireland does not have a public cord blood bank Expensive Public banking wastage considerable bank less than 10% of all samples taken Irish Stem cell Foundation promotes research and lobbies for improved legislation to permit research

14 Legislation Human tissue removal and use is regulated throughout Europe under the EUTCD In Ireland this is the remit of the Irish Medicines Board (IMB) Role of the Responsible Person License Holder (for private banks is actually under UK legislation) Traceability, safety, efficacy, CONSENT Training of all people involved in all processes

15 What does this mean? Training does not just mean how to take the sample Reporting of events Legislation Customer service Process begins with explaining service and taking consent Parents have to be aware of WHO does what and WHY The procurement is usually entirely separate from the birth management Parents also need to know their role And to call courier when sample has been taken

16 Reporting requirements SAE or SAR Serious Adverse Event or Serious Adverse Reaction EUTCD 2004/23 Article 2 point 2 m specifies that "Serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity."

17 Reporting responsibilities Responsible Person or nominated person needs to report this within 24 hours of being made aware of this Can be reported by more than 1 establishment In the UK is the responsibility of the DI to report and investigate Full report to be completed in reasonable timescale from initial report Should include corrective actions where necessary

18 Cells4Life training NAP trained trainer Also experienced midwife and phlebotomist C4L designed course approved by HTA Course accredited by NAP Practical and theoretical aspects Use of a mock up placenta Reviewed annually Will need to be approved by IMB and be able to show a person having gone through this process

19 For the Procurer How to handle clients from the outset Managing expectations e.g. cord clamping, when to call How to handle working at a Trust but not as employee H&S requirements Where to go Who to contact if there is a problem Where are disposal places? Understanding how to determine birth progress Labours are all different Getting there before the birth is imperative Parents don t want to be distracted by waiting for someone to arrive at this time You need time to prepare too Hospitals may have different rooms to use Where is the client?

20 Practical issues Are mum and baby (ies) well? Any reason not to go ahead? Midwifery staff happy with health of mum and baby Tough membrane on cord Clotting process already activated once the placenta is delivered Timing is key Preparation of materials necessary Nucleated cell count 1.2e09 and rising Document everything

21 Safety Mother s are screened in pregnancy BUT you have to assume samples are infected People may be doing this because of disease trait in the family Making a puncture site in the tough membrane of the cord is NOT the same as someone s arm ANY cross contamination of samples e.g. maternal to foetal or procurer to foetal can cause complications in a recipient Disposal of sharps, the placenta when done etc

22 Cells4Life Procures largest number of UK samples Oldest cord blood bank Offices across Europe, Middle East, Africa Most UK samples are procured by phlebotomists Most non-uk samples are procured by midwifery / obstetric staff Does not have IMB license Need Responsible Person based in Ireland Need to demonstrate training course Pay the fees

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24 Processing of cord blood in the lab Whole cord blood Volume reduced Assess blood volume Take viability sample Add DMSO Aliquot (reference samples always available) Take microbiology sample Freeze (controlled rate) Assess blood volume Process using AXP device* Create buffy coat Viability sample Microbiology sample Add DMSO Freeze (controlled rate) Any sample volume possible, just adjust bag(s) and vial(s) accordingly *45ml to 160ml ONLY

25 How to do a collection Practical demonstration

26 Conclusion Cord blood is very useful Cord blood is USED and for more than bone marrow replacement in leukaemia Risk to donor virtually nil Cells4Life could apply for an IMB license but the ability to service this needs to be confirmed Procurers have to be trained and licensed In taking a sample safely you can save a life

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