Oral Abstract| Volume 17, ISSUE 6, SUPPLEMENT , S14-S15, June 2015

Cost of stem cell-based tissue-engineered airway transplants in the UK: Case series

      Stem cell-based tissue-engineered tracheas are at an early stage in their product development cycle. Approximately tens of patients have been treated worldwide in compassionate use settings, demonstrating significant promise. They generally constitute cells obtained from the patient (autologous) seeded onto a non-immunogenic scaffold, in order to create a bespoke, personalized, treatment that avoids the need for immunosuppression. This potentially life-saving treatment is thus complex, involving the composition of a 3D tissue engineered graft containing multiple cell types, which is capable of being safely transplanted into the patient and then integrated into the body. The cost and its implications for such treatments have yet to be fully understood and are compounded by varying strategies for graft preparation and transplant, resulting in differing clinical and laboratory costs from different research groups. Since 2009, three UK patients have received stem cell engineered airway transplants, including the first transplant of this kind in a child. All three cases had full local ethical approvals and were treated entirely according to UK Compassionate Use legislation, using products prepared in a (Good Manufacturing Practice) GMP laboratory with the necessary Specials License. Whilst the safety, efficacy and viability of the novel treatment is of primary concern, affordability and an ability to offer reimbursement is vital if this therapy is ever to be incorporated into routine healthcare in the public and/or private clinical setting. Here we present a summary of all the clinical and manufacturing costs for these three patients. This is the first time such a detailed financial analysis has been made for a tissue-engineered organ and provides a benchmark for subsequent studies.
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