The INSPIRE consortium, led by Videregen Ltd (Liverpool, UK), has received approval from the UK MHRA to conduct a clinical trial using their replacement trachea technology, which will commence next year.
The INSPIRE project started in 2014, and has £1.9m of funding from Innovate UK. Led by Videregen Ltd (Liverpool, UK) and involving a team of UK experts such as the Cell Therapy Catapult, NHS Blood and Transplant, the Royal Free London NHS Foundation Trust, Videregen and UCL, the INSPIRE consortium has received MHRA1 approval to start a UK clinical trial with its tissue-engineered replacement trachea.
Severe structural airway disease (SSAD) is a potentially life-threatening condition believed to affect 19,000 people in Europe and the USA, and is associated with significant airway obstruction, and if not treated successfully, resulting in significant morbidity and mortality. Surgery is an existing therapy, but has low success rates and low efficacy. The developed replacement trachea technology has the potential to be a one-off treatment for SADD that doesn’t require patients to take immune suppressants throughout life afterwards, as it involves repopulating an acellular trachea scaffold with each patient’s own stem and epithelial cells.
The Phase I clinical study, be led by Professors Martin Birchall and Mark Lowdell at UCL, is expected to begin in the first half of 2016, and will enroll four patients with SSAD to investigate the product’s safety and initial efficacy. Although replacement trachea technologies have been tested in compassionate use cases, this is the first formal clinical trial of a tissue-engineered autologous stem cell trachea replacement.
Speaking for the consortium, who have each been involved in various steps to develop and apply the product, Dr Steve Bloor, CEO of Videregen, commented: “Approval from the UK MHRA for this clinical trial is an important milestone for Videregen and the INSPIRE team, moving this transformative approach to airways disease one stage closer to market. The consortium approach, bringing together expertise from the Cell Therapy Catapult, clinician scientists at UCL, NHS Blood and Transplant and the Royal Free London NHS Foundation Trust, has enabled us to make good progress with this exciting project.”
With the Cell Therapy Catapult acting as clinical trial sponsor and proving regulatory expertise, Videregen providing the decellularization technology, and so on, the consortium is an excellent example of collaboration and demonstrates the positive impact it can have on the development of potential regenerative medicines.
Speaking on the importance of the trial, Bloor believes that it is “critical in transforming trachea replacement from occasional compassionate use to a treatment that could benefit thousands of patients.”