Bronchopleural fistula (BPF) is an abnormal opening between the airway and pleural cavity, causing serious, sometimes fatal, infection and other complications. It is a complication of thoracic surgery occurring in 1.4%-14% of patients and can be associated with high mortality (up to 50%), often requiring multiple procedures, prolonged hospitalization, and very poor quality of life.

There is no standardized treatment for BPF. Literature reports describe the preliminary use of mesenchymal stem cells (MSCs) as a potential treatment. The inclusion of a biologically relevant extracellular matrix (ECM) scaffold seeded with MSCs, may offer a considerable improvement in treatment outcomes compared to MSCs alone, particularly for large (more serious) BPF defects. 

Using a tissue-engineered approach Videregen’s proprietary solution combines and builds on the reported use of ECM scaffolds and MSCs to provide an innovative option for curative treatment of BPF, reducing morbidity, mortality, and prolonged hospitalization costs. 

Project goals
1. Generate human safety and efficacy data to support the future transition to pivotal clinical trials and eventual marketing authorization
2. Establish tissue engineering approaches/solutions using tissue scaffolds and cells as a viable and effective regenerative clinical solution
3. Develop and investigate the science underpinning the regenerative processes and mechanisms of tissue engineering