Liverpool and London, UK - November 3 2015: The INSPIRE consortium, led by
Videregen Ltd, has received approval from the MHRA1
to start a UK clinical trial with its tissue
engineered replacement trachea. The trial, which is expected to start in the first half of 2016,
will focus on severe structural airway disease (SSAD), a potentially life-threatening condition
believed to affect 19,000 people in Europe and the US. Along with Videregen as commercial
partner, the consortium includes the Cell Therapy Catapult, University College London (UCL),
NHS Blood and Transplant in Speke and the Royal Free London NHS Foundation Trust.
The Phase I trial, which will recruit four patients with SSAD, is to assess the safety and initial
efficacy of the product. While replacement trachea technologies have been tested previously
in compassionate use cases, this is the first formal clinical trial of a tissue engineered
autologous stem cell trachea replacement. The INSPIRE project started in 2014, and has
£1.9m of funding from Innovate UK.
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The INSPIRE clinical trial will be led by Professors Martin Birchall and Mark Lowdell at UCL
with the Cell Therapy Catapult as clinical trial sponsor and a provider of regulatory expertise.
Videregen’s proprietary decellularisation technology, originally developed at Northwick Park
Institute for Medical Research, is used by NHS Blood and Transplant to manufacture the
trachea scaffold. The Centre for Cell, Gene and Tissue Therapy at the Royal Free London
NHS Foundation Trust has developed the stem cell seeding processes so that the final
product can be manufactured in its state-of-the-art facilities.
http://www.videregen.com/wp-content/...1-15-FINAL.pdf