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HTA Licence 22520
Procurement of Tissues and Cells for Human Application
ISO 9001-2008 for Procurement, Distribution, Import/Export of Tissues and Cells for Human Application.
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0800 11 CELLS (23557)
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Section 1. Umbilical Cord Blood Stem Cells 1) What are stem cells? They are a unique type of growth cell, the original building blocks of life for the developing embryo in the womb. They turn into the different types of cells needed to make up the child, from heart muscles and skin tissues to red blood cells. Once separated from the cord blood, they can be stored in gas phase of liquid nitrogen, and can be multiplied in the laboratory. They are brought out of storage if and when the person becomes ill and requires stem cells' transplant. 2) What illnesses can the cells treat? The main use so far has been childhood leukaemia and some other cancers, but potentially the cells could be used to treat illnesses such as diabetes, strokes, multiple sclerosis, osteoporosis, brain and muscle diseases, Alzheimer's and Parkinson's diseases. 3) What is the characteristic that enables these cells to "cure" a diseased blood system, as with leukaemia? It is the renewing properties of the cells which allows them to be used as a treatment. The diseased cells must be completely removed by chemotherapy and in some cases radiotherapy. The umbilical cord stem cells can then be given intravenously to the patient and they will build a complete new blood system and maintain it for years to come. 4) How likely is it that my child will ever need these cells? Hopefully never. If you think about it as an insurance policy, you always hope that you don't have to use it, but if you do it's there. 5) What is the possibility of matching with in my family? There is a one in four (1:4) chance that siblings will match. This ratio goes up exponentially for parents and grandparents. 6) What happens to these cells after 25 years? We believe that the cells will be viable indefinitely. There is no evidence to support that the cells will deteriorate after 25 years. In fact, the first sample that was stored was in 1979 and is still viable today. After 19 years, we will contact our clients allowing them the option to continue storing their sample. 7) What is the difference between cord blood stem cells, embryonic stem cells, and bone marrow stem cells? a) Stem cells from the umbilical cord are more flexible than stem cells taken from an adult's bone marrow. Umbilical cord blood stem cells are the predecessors of adult stem cells, and have the ability to divide into each type of cell, whereas bone marrow stem cells may have a more difficult time dividing. b) Umbilical cord blood stem cells have a greater repopulating potential than bone marrow stem cells. c) Bone marrow and peripheral blood stem cell collection are painful and complicated procedures. d) There are also many instances when bone marrow or peripheral blood stem cells cannot be used, which would mean finding a donor. e) Embryonic stem cells are cells that are taken from a 0-14 day old embryo. They are the richest form of stem cell but are associated with many ethical, religious, and legal issues. 8) Do you think people get confused between obtaining stem cells from un-needed embryos, bone marrow, and now umbilical cord blood? Is the confusion understandable, or is at all the same science? There is confusion as to the sources of stem cells and these sources are very different. Embryonic stem cells are a completely different set of cells compared to umbilical cord blood stem cells and they are regulated by the government. At the scientific level the concepts are similar but embryonic stem cells raise many legal, ethical and moral questions which umbilical cord stem cells do not. 9) Is it possible to obtain stem cells later in life? Yes, stem cells can be found in our bone marrow where they continue to generate new blood cells throughout our lives. But cord blood stem cells have a number of important advantages over bone marrow. Cord blood stem cells are easier to obtain than stem cells from bone marrow, and treatments using cord blood stem cells can be less costly than bone marrow transplants. Additionally, the collection of cord blood is a quick, non-invasive and painless procedure with no risk to the mother or newborn. More important, however, is the fact that cord blood stem cells are a perfect match for the child they are collected from, thus eliminating the difficult process of finding a matching donor and minimizing the risks of rejection. Umbilical cord blood stem cells have a 1:4 (25%) chance of being an exact cell match for a sibling. Section 2. The Collection Procedure 1) How is the collection done?
A blood collection kit is issued to new mum long before she goes into labour. This enables the authorised healthcare professional to assist by extracting blood from the cord, after the baby is safely delivered. With the kit, we provide detailed instructions for safe collection of cord blood. You may also view the collection procedure online which is under the services menu.
2) Who actually does the collection?
3) What volume of blood needs to be taken? b) It is possible to test a smaller sample, but the likeliness of attaining a sufficient sample is smaller. 4) What is the average amount of blood you have received? a) The average is around 85ml 5) What do I do with the sample after collection? Have someone call DHL to arrange a pick-up at the hospital or home if it is a home birth. Our account number with DHL is documented within Sending Procedure that we also supply with the Collection Kit. 6) Should I put it in the refrigerator? Never put the sample in the fridge or freezer. This will cause the blood to start clotting. Always keep the sample at room temperature until DHL arrives. 7) Are there enough stem cells in the cord blood for treatment? The amount of cells necessary is proportional to the weight of the patient, so the change is better for a child than for an adult. But doctors are trying to increase in number the stem cells present in the blood specimen. 8) Can the blood be collected from the umbilical cord when it is cut already? Yes, the umbilical cord is clamped and cut in the same manner, as it would be for normal delivery. 9) Is it also possible to collect the cord blood when the delivery is taking place at home? Of course, procedure is the same for collection of cord blood. 10) How long the blood sample can wait before processing? Cells propriety developed, temperature controlled kit beside safe transportation ensures viability of blood sample at least for 96 hours. This assertion is based on our labs long term experience in cryobiology having stored thousands of samples. 1) Are you a private company? Yes. Registered in England and Wales no. 5057305. We have stored from all around Europe including all European partner a total of 200,000+ samples. We are licensed by the Human Tissue Authority (HTA), as well as have a ISO 9001-2008 for the procurement, distribution, import and/or export of tissues and/or cells for human application. 3) How many successful transplants have you been involved with? Cryo-Save Group has been involved with 10 successful transplants. (Last updated May 2022). 4) What will you do with the cells as the years go by? Nothing. We store your baby's cells for his/her future use and that's it. We do not have anything to do with research and as the contract states you are the only people with the right of access to the cells. They are your property. 5) Are you affiliated with a hospital or research lab? No The cost is £195.00 inc. VAT for the kit and £1450.00 for the storage and processing of cord blood and £1950.00 for cord blood and cord tissue. (UK) 7) Do you issue a report after freezing the sample? We issue a certificate of storage, with the lab's contact details and storage details. If exact number of cells is asked for, we can provide a report as such. 8) Do you operate your own storage facility or lease space from another facility/company? We are a partner of the Cryo-Save Group, Europe's leading stem cell bank who operate their labs in Belgium and The Netherlands for storing our clients stem cells. 9) Is there a storage facility in the UK? No, and this is due to the fact that we have stronger resources locatable in one place instead of having labs all over Europe. 10) What guarantees do you have against your company going into bankruptcy and our family losing our cells? We are backed by our European partners, the Cryo-Save Group which is operating in 38 countires and is listed on NYSE Euronext Amsterdam. Our lab has made financial provision for each and every client, through a company specialised in Cryo-preservation. The safe storage over the agreed period is therefore fully guaranteed. 11) What measures of security are taken to ensure security of the samples? a) The laboratory is a highly secure facility with restricted and limited access. b) Each client has a seperate client ID which is generated the day a kit is ordered. When the lab receives the blood, a sample ID is created, and each storage bag has an individual bar code. All these numbers relate to the client and the sample and are cross checked at every stage of the process. c) We operate a dual storage system therefore storing two samples of your baby's stem cells in two seperate, purpose build, underground storage rooms, to give added security. 12) How do you ensure client confidentiality? a) We feel that customer service and client confidentiality is the most important part of our service. b) We operate under the Data Protection Act. Section 4. General and Miscellaneous questions 1) Can I get stem cells from a public bank if I need them? 1) Can I get stem cells from a public bank if I need them? This could be possible, but would depend on finding a suitable match which becomes increasingly difficult if you belong to certain populations, such as ethnic minorities, or mixed raced families. 2) Where can I donate instead of privately storing? At present, you may be able to donate the cells, but you would have to deliver your baby at one of the NHS hospitals with their own labs. i) Northwick Park ii) Barnet iv) Dublin v) Glasgow 3) Is collection available on the NHS? Not on any large scale. That's because the NHS does not have the resources to enter into a huge programme of collection and storage. Some NHS hospitals are taking samples for research purposes, in the hope that one day banks of Stem Cells might be available for the whole population. The Government has started a stem cell bank, but the "lines" of stem cells produced for research will be from embryos. 4) Why are some midwives and consultants difficult about collecting cord blood? a) Experience has shown that it is not always possible to collect enough blood from the umbilical cord or placenta for various reasons, secondly it may not be possible to collect enough stem cells despite the fact enough blood had been collected, as such there are two common misconceptions in the medical community. (1) Sometimes they think that if they don't collect enough blood or something goes wrong with the sample that the patients are going to sue them, or hold them liable. This is not the case, due to the fact that we have all our clients sign agreements before their baby is born, which states that the hospital or its staff will not be held liable in any way. b) (2) They sometimes think that this is a lengthy procedure. Again, this is not the case. The entire procedure can take between 5 and 10 minutes. When the midwife has not done it him/herself they don't realise how easy it is. Additionally it is the same process as taking blood for a rhesus negative mother, and the midwives are trained for that. 5) If a sample is required, what is the procedure of thawing and transport? a) If a sample is required, retrieval and transport is included in the total service cost. b) We require the parents to request for the sample in writing, and we will arrange for the sample to be delivered directly to your physician at your hospital. c) The thawing protocol and all essential information will be supplied to the physician by Cryo-Save Labs. 6) How many times can the stem cells used? This is a relative question, and depends on the size of the sample. The sample can possibly be used at least twice because there will be two bags available. Additionally future amplification will allow more treatments. 7) Can the cells be successfully multiplied in vitro, where for example the patient was large, for example in the case of an adult? In vitro multiplication is currently in the experimental phase but in the future it should be possible to multiply cells in vitro so that a sufficient dose can be obtained for all treatments and individuals. 8) Are there any additional costs for retrieving a sample? There are no hidden costs. Retrieval and transport are included in the service fee. 9) Is it better if the transplant is autologous, i.e. your own, or is a "match" good enough from a donor? The ideal transplant is autologous but there is an increasing amount of evidence which suggests that a basic match or even mismatched cells could provide useful transplants. Further work is needed in this area to truly understand the immunology of these cells. 10) Given the current interest, do you see these cells becoming a vital part of the every-day treatment of serious illness in the future, if so, how far in the future? The current storage of umbilical cord stem cells at birth means that we are already at the stage where they play a vital role in the treatment of deadly disease. We feel that this technology will increase to be common-place in the future (5-10 years) in the treatment of a whole range of diseases. Click here to view the agreement. (PDF document) 1) Is the laboratory accredited? And by who? 1) Is the laboratory accredited? And by who? Cryo-Save Group: Yes, the Cryo-Save Labs established in EU member states are authorised by their local government regulations. 2) Who carries out the quoted inspections of the laboratory? Inspections, Quality Control is managed and supervised under control Cryo-Save Group. 3) Is the blood sample tested for diseases and contamination? a) The sample is tested for contamination. b) We also carry out blood tests for Syphilis, HIV, Hepatitis B, and Hepatitis C and CMV on maternal blood as well as NAT/PCR on the cord blood sample.. 4) What is the sample stored in? i.e. vials or bags A minimum of 2 bags. 5) How long does it take from collection to being frozen? a) There is a 96 hour window period for safe transport of the cells from the hospital to the laboratory. However, samples are stored as soon as the processing and testing is completed. b) The laboratory will process the sample as soon as they get it. The faster the sample arrives to the lab, the faster it goes into storage 6) What temperature is the sample frozen at? -196º Celsius 7) How are the cells stored, by deep freezing, and is this procedure already well established? The cells are stored by slowly cooling them to the temperature of gas nitrogen which is -196 degrees Celsius. Chemicals are added to prevent damage to the cells during the freezing process. Once frozen the cells are completely stable and can be kept in this state for many years. The technology used is very well established in the field of IVF, but embryos can not be stored for anything like as long as stem cells. 8) How are the stem cells separated from the cord blood, and what percentage are they. How many stem cells can be collected from the blood sample? This largely depends on the volume of blood collected but a range of 50,000 to 200 million stem cells can be obtained, representing about 0.1-3.0% of the total number of cells. The cells are obtained by standard centrifugation techniques which allow the unwanted cells to be largely removed and the stem cells to be concentrated. 9) Why do we perform PCR tests on the Cord Blood? 1. At Cryo-Save Labs we use state of the art laboratory practice. Therefore we were the first to introduce PCR-testing on the cord blood samples. PCR is a novel method to test the presence of a virus or a parasite instead of testing for antibodies. 2. The requirement as per HTA Direction 003/2010 are followed and tests are performed on the maternal blood collected at time of birth and the cord blood PCR/NAT is conducted.. 3. Since we perform PCR testing on the CORD BLOOD, we do not need to retest, as is the case when one tests SEROLOGICALLY on the mothers' blood. 4. We don't waste cord blood stem cells because we perform PCR Tests on the leftover of cord blood after processing. 5. Following PCR tests are performed to determine the health of the specimen: Lues Serology (bacteria that causes syphilis) , CMV IgG (Cyto Megalo Virus) , Hep B , Anti-HepC AB & Anti HIV 6. The process followed at our Cryo-Save Labs does not contravene any HTA regulations. |