毓璜顶医院启动全球首个外泌体雾化治疗哮喘临床研究

Core Viewpoint - A milestone clinical study has been launched at Yantai Yuhuangding Hospital, focusing on the safety and tolerability of nebulized umbilical mesenchymal stem cell exosomes (MSC-Exo) for treating moderate to severe asthma, marking a significant innovation in regenerative medicine for respiratory diseases [1][3]. Group 1: Clinical Study Overview - The study is a single-center, randomized, single-arm Phase I clinical trial, registered under ChiCTR2500105903, led by Professor Song Xicheng in collaboration with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd [1][3]. - This is the first international clinical research exploring nebulized inhalation of stem cell exosomes for asthma treatment, indicating a pioneering step in the field [1][3]. Group 2: Treatment Methodology - Asthma, a prevalent chronic airway inflammatory disease, often sees patients struggling with inadequate efficacy or side effects from traditional therapies [3]. - The use of umbilical mesenchymal stem cell exosomes is considered a promising new treatment due to their strong immunomodulatory, anti-inflammatory, and tissue repair potential [3]. - The innovative nebulized delivery method aims to directly target the lungs, enhancing the efficiency and precision of asthma-related inflammation and remodeling control while minimizing systemic side effects [3]. Group 3: Institutional Support and Collaboration - The hospital emphasizes the scientific value and potential patient benefits of the study, committing to support the research team for high-quality project completion [4]. - The clinical research management office will collaborate with researchers to advance the project with a rigorous scientific approach, aiming to provide high-quality evidence for new treatment pathways for asthma patients [4]. - Shandong Qilu Cell Therapy Engineering Technology Co., Ltd will supply high-quality MSC-Exo formulations compliant with GMP standards and provide technical support for the clinical team [4]. Group 4: Research Goals and Significance - The Phase I clinical study will initially focus on assessing the safety and tolerability of nebulized MSC-Exo at different doses in moderate to severe asthma patients, which will inform subsequent larger-scale efficacy studies [6]. - The outcomes of this research are expected to offer new treatment options and hope for asthma patients, filling an international research gap in nebulized exosome therapy for respiratory diseases [6].