Periodic Reporting for period 2 - TETRA (Autologous Stem Cell Seeded Tissue Engineered Trachea)
Período documentado: 2017-07-01 hasta 2018-12-31
There are an estimated 11,827 patients with severe structural airway disease in Europe. Even with the current standard of care, when hospitalised this group of patients has a 22% risk of dying. Patients are currently subjected to repeated surgical interventions (stent insertion, balloon dilation) which have a high failure rate leading to a poor quality of life for these patients.
Other therapeutic strategies under development include synthetic tracheal scaffolds seeded with patients own stem cells. Preliminary data show that these scaffolds are poorly integrated and are susceptible to infection.
Our project will address the limitations of standard clinical care and will:
• Build on our successful compassionate use experience using autologous stem cell seeded scaffold-tracheal transplants.
• Follow on from our Phase I 4 patient INSPIRE clinical trial which will improve on the clinical prototype used in compassionate use cases.
• Conduct a Phase II pivotal clinical trial to provide robust, quality data with validated to Good Manufacturing Practice to support an
accelerated route to market for commercial exploitation in this orphan indication. Phase II trial will be completed in line with Good Clinical
Practice meeting all required ethical and regulatory requirements.
• Prepare a dossier for Market Authorisation Application submission.
Other therapeutic strategies under development include synthetic tracheal scaffolds seeded with patients own stem cells. Preliminary data show that these scaffolds are poorly integrated and are susceptible to infection.
Our project will address the limitations of standard clinical care and will:
• Build on our successful compassionate use experience using autologous stem cell seeded scaffold-tracheal transplants.
• Follow on from our Phase I 4 patient INSPIRE clinical trial which will improve on the clinical prototype used in compassionate use cases.
• Conduct a Phase II pivotal clinical trial to provide robust, quality data with validated to Good Manufacturing Practice to support an
accelerated route to market for commercial exploitation in this orphan indication. Phase II trial will be completed in line with Good Clinical
Practice meeting all required ethical and regulatory requirements.
• Prepare a dossier for Market Authorisation Application submission.
D1.1. - Complete.
D1.2. - Complete.
D1.3. - Complete.
D2.1. - Complete.
D2.2. - Complete.
D2.3. - Complete.
D2.4. - Complete.
D4.1. - Complete.
D5.1. - Complete.
D6.2. - Complete.
D6.3. - Complete.
D6.4. - Complete.
D1.2. - Complete.
D1.3. - Complete.
D2.1. - Complete.
D2.2. - Complete.
D2.3. - Complete.
D2.4. - Complete.
D4.1. - Complete.
D5.1. - Complete.
D6.2. - Complete.
D6.3. - Complete.
D6.4. - Complete.
Our product, an Advanced Therapy Medicinal Product, aims to eliminate the need for repeated surgical interventions that are high risk and of limited efficacy, reduce deaths and improve the quality of life for surviving patients. If treating 20% of the patients with severe structural airway disease, we estimate that in Europe our technology will improve the quality and length of patient lives and result in savings of €517 million per year.