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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© 2015 Published by Elsevier Inc.
