Date: 2015-11-02
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Videregen (UK)
Product: tissue engineered replacement trachea
Action
mechanism: cell therapy/stem cell therapy. SSAD is associated with significant airway obstruction leading to high levels of morbidity and a 50 percent mortality rate if not treated successfully. Current treatment involves surgery which has a high incidence of failure and lack of efficacy. In contrast, this tracheal replacement approach, which involves repopulating an acellular trachea \'scaffold\' with the patient\'s own stem cells, is designed to be a one-off curative treatment without the need for a lifetime of anti-rejection drugs thereafter.
Disease: severe structural airway disease (SSAD)
Therapeutic area: Respiratory diseases - Regenerative medicine
Country: UK
Trial details:
Latest
news: * On November 2, 2015, the INSPIRE consortium, led by Videregen Ltd, has received approval from the MHRA 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 GBP 1.9 million of funding from Innovate UK. 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.
