(i) Technical complexity- identifying and purifying the correct cells, under tightly controlled laboratory conditions means the workup prior to any clinical trial is a technically challenging endeavour. The current situation reflects two key challenges that remain to be addressed by the panoply of organisations involved in the development and regulation of these therapies including the Medicines and Healthcare products Regulatory Agency (MHRA), the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA), the Genetic Therapy Advisory Committee (GTAC) and the Health Research Authority (HRA) in the UK. Subject to regulatory approval, experimental stem cell therapies can sometimes be offered as ‘one-off’ specials on a named patient basis. So why aren’t more people being offered a stem cell therapy now?Ĭurrently, the only clinically approved uses of stem cell therapy in the UK are limited to bone marrow stem cell transplants for leukaemias and lymphomas, skin cells for repairing skin in the case of burns, and corneal stem cells for some forms of ophthalmic disorders. This includes some types of Chimeric Antigen Receptor (CAR) T-cell therapy, similar to the treatment received at Great Ormond Street Hospital by Layla Richards. Genome editing can be used, in an advanced form of immunotherapy, to add in genes, giving the immune cells the ability to recognise specific cell markers on the malignant cells and destroy them. Stem cells can also be combined with advanced genome editing techniques, potentially heralding a new era in cancer treatment – to the extent that they have been described as the ‘fifth pillar’ of cancer treatment. One example of this wider application of stem cells is the growth of laryngeal implants for transplant in patients with stenosis of the upper windpipe or voicebox, using an anatomical scaffold seeded with cartilage and mucous-membrane cells derived from the patient’s own bone marrow stem cells. The use of adult stem cells has some advantages, so the discovery that they could be used in a number of different therapeutic contexts was important, not least because such an approach avoids the ethical, regulatory and technical challenges associated with embryonic stem cell use. Technological advances are paving the way for the growth of a greater variety of tissues and organs for transplant using a wide array of adult stem cells. Stem cell transplants are well-established for use in treating blood cancers, where bone marrow stem cell transplants have been in use, to great effect, since the 1970s. For example, researchers are examining the use of stem cells to repair damaged heart tissue following a heart attack. Stem cell therapies make use of relatively unspecialised cells which can be converted (inside or outside the body) to more specialised cell types that can repair or restore function to diseased or damaged tissue or to provide therapeutic functions. In our appraisal of the technology, we’ve focused on the latter. There are four distinct sources of stem cells which may be used in stem cell therapies: embryonic stem cells, cord blood stem cells, induced pluripotent stem cells, and adult stem cells. What are stem therapies? - view our updated explanation here What are stem cell therapies and what can they do? Enthusiastic reporting in the press might lead us to think we are just around the corner from a paradigm shift towards cellular therapeutics for diseases as diverse as Alzheimer’s, diabetes and cancer, but what’s really going on in the research laboratories, and hospital clinics? It’s easy to see the allure of therapeutic strategies that can promise a potentially limitless supply of cells without issues of rejection, or living drugs which can replace a raft of potentially toxic pharmaceuticals. Consequently, funding for research and development in this field, both in the UK and abroad, continues to be a major priority for governments and industry. The level of excitement, justified or not, surrounding the stem cell science and its therapeutic benefits is enormous. Regenerative medicine, a field that encompasses stem cell therapy, has been described by George Osborne as one of the UK’s ‘eight great technologies’.
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