Autologous Stem-Cell Based Tissue Engineered Treatment for Bronchopleural Fistula

“支气管胸膜瘘（BPF）是气道（支气管或气管）和胸腔之间的异常孔。当BPF发生时，呼吸的空气可以通过异常孔进入胸腔，这可能导致危及生命的感染。BPF是一种罕见但可能致命的肺部手术并发症，死亡率很高。它特别发生在因肺癌切除肺后，有时发生在肺移植后。治疗通常需要多次手术，长期住院，并对生活质量产生重大影响。尽管手术技术不断改进，治疗方法也不断进步，但仍缺乏一种标准化、可靠的治疗方法。该项目旨在测试一种新的、有可能治愈BPF患者的治疗方法，即通过使用组织工程补片，植入患者自身的干细胞（从骨髓中培养），以封闭穿孔。研究表明，组织支架和干细胞可以帮助愈合过程，促进血管再生，减少炎症反应，从而改善组织再生。捐赠的人体气道组织将使用Videregen的专有技术进行处理，以去除细胞和细胞残留物。患者自身的干细胞将用于种植气道组织支架，其中一部分（补片）可用于关闭患者气道中的孔。该项目将在5名患者中完成初步临床试验，以评估组织工程干细胞种植补片的安全性和初步有效性，生成数据以支持进展到更大的临床试验，以进一步测试组织工程化药物产品的功效。最终，有可能为患有这种严重衰弱疾病的患者提供治愈性治疗，并为将该技术扩展到其他严重疾病提供支持，这些疾病缺乏器官替代选择或供应短缺。"

"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."