Autologous Stem-Cell Based Tissue Engineered Treatment for Bronchopleural Fistula

"A bronchopleural fistula (BPF) is an abnormal hole between the airway (bronchus or trachea) and the chest cavity When a BPF develops, air that is breathed can travel through the abnormal hole and enter the chest cavity, which can result in life threatening infection. BPF is a rare but potentially fatal complication of lung surgery with high death rates. It occurs particularly after removal of a lung for lung cancer or sometimes after lung transplantation. Treatment often requires multiple surgeries, long hospital stays and a major impact on quality of life. Despite improvements in surgical techniques and advances in treatment options, a standardised and reliable treatment option is still lacking.

This project aims to test a new, potentially curative treatment for patients suffering with BPF, through use of a tissue-engineered patch, seeded with the patient's own stem cells (which are grown from their bone marrow), to seal the hole. If successful, this will allow permanent healing of the fistula and more rapid recovery of the patient.

Studies have shown that tissue scaffolds and stem cells can aid in the healing process, encourage revascularisation reducing the inflammatory response, and so improve regeneration of the tissue. Donated human airway tissue will be processed using Videregen's proprietary technology to remove cells and cellular remnants. The patient's own stem cells will then be used to reseed the airway tissue scaffold, a portion of which (a patch) can then be used to close the hole in the airway of the patient.

This project will complete an initial clinical trial in 5 patients to evaluate the safety and initial effectiveness of a tissue-engineered stem cell seeded patch, generating data to support progression to a larger clinical trial to further test the efficacy of the tissue engineered medicinal product. Ultimately, has the potential to provide a curative treatment for patients suffering from this severely debilitating condition and provide support to expand the technology to other serious conditions, where organ replacement options are lacking or in short supply."