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What is a stem cell? • Stem cells can divide and make copies of themselves (called ‘self-renewal’). • Stem cells can also make other, more mature cell types, tissues or organs (called ‘differentiation’). How does a stem cell treatment become ‘proven’? • The tissue-specific (‘adult’) stem cells in your body can only make related cell types (e.g., blood stem cells make blood cells). Assessment of proposed stem cell treatments through clinical trials is used to determine the treatment’s safety and effectiveness, with the results published for transparency and further education. • Pluripotent (‘embryonic’, ‘reprogrammed’, ‘induced’) stem cells grown in the laboratory can make all cell types in the body. It is hoped stem cells, and the cells they make, may eventually provide new treatments to help repair or replace damaged and diseased cells in the body. What is an UNPROVEN stem cell treatment? Where doctors offer to treat patients without first properly evaluating the proposed treatment and risks, effectively circumventing the clinical trial process. Key signs of an UNPROVEN stem cell treatment are: • The treatment isn’t part of a registered clinical trial. • Many diseases are treated with the same type of stem cell and procedure. • Patient testimonials are used to support claims of benefit with no independent verification, and no published scientific papers. • The treatment is advertised to you on the Internet, TV, radio or by newspaper advertisements, rather than by referral from your treating doctor. What is stem cell tourism? Travelling within Australia or overseas to obtain an unproven stem cell treatment. Are there risks with UNPROVEN stem cell treatments? Yes, complications and even deaths have been reported from unproven stem cell treatments. Before you make a decision be sure to take the information you gather back to your treating doctors for independent advice on what is most suitable for you. Just because a treatment is being offered in Australia does not make it a proven, safe and effective therapy. Australian Stem Cell Essentials How can I assess if a stem cell treatment is UNPROVEN? The information contained in this brochure is to be used to assist you in your search for more information to then take and discuss with your treating doctors. • When it is claimed there are no risks involved in the treatment. • When you are asked to pay for a treatment that is not yet an accepted medical practice. • When there is no Medicare or private insurance rebate for the treatment. Disclaimer: This brochure must not be relied upon as a substitute for medical or other professional advice. Please seek independent medical advice. Supported by the University of Western Sydney Questions to ask a stem cell treatment provider - Is this an UNPROVEN TREATMENT? Ask about the treatment: Ask about the procedure: Is this an accepted medical procedure, if so by whom is it approved? What type of cells are you using – mine or someone else’s? Is the treatment considered ‘experimental’? If using donor cells, where do they come from – fetal tissue, embryos, umbilical cord blood? If so, is it being offered as part of a clinical trial? If part of a clinical trial, is the trial registered on ANZCTR, NIH Clinical Trials or other recognised registries? What is the evidence that this treatment will work for my condition? Can you provide me with peer-reviewed publications that can support the likely benefit? Have you published your data? If so, where? Are there any risks associated with the treatment? What are the side-effects? Could the cells harm me? Could they form tumours or cause problems with my immune system? Are they human or from other species and if so which? Are the donor cells screened for viruses (HIV, Hepatitis B, Hepatitis C, HTLV-1 and HTLV-2)? Are the cells prepared in a licensed laboratory or using an approved device? And if so, by whom? Do you use animal products to grow the cells and how do you guarantee there is no contamination? Has this treatment been reviewed by an ethics committee, and if so which one? If offered in Australia, is this treatment eligible for a Medicare or private health insurance rebate? Who is the doctor performing the treatment? Is he/she a specialist in treating my condition? Will I receive any other treatments or therapies when I am at the clinic? If so, does this attract an additional cost? What ongoing care will I receive? Does this attract additional charges? How will my health be evaluated after the treatment? What happens if something goes wrong? Who do I contact? How are the cells delivered? Are they injected? Who will cover the costs of any medical complications? If so, what are the possible complications of the injection? If travelling overseas, will my travel insurance cover my treatment? Do I need to take medication after the treatment? Will my travel insurance help me get home if I have a reaction or get sicker? What is the cost and exactly what does this include? How many visits are required? Is there a new fee for each visit? Ask about medical care and other considerations: This checklist has been taken from the Australian Stem Cell Handbook. For more detailed information please view this handbook at: www.stemcellfoundation.net.au/patientinformation/handbook If travelling overseas, are there likely to be additional costs or are these included in the fee (e.g., travel, accommodation, meals, insurance, medications, hospital bed costs, consumables used during the treatment, cell processing costs)?