Ruijian Medicine Successfully Launches Clinical Trials of NouvSoma001, a First-in-Class Chemically Induced Extracellular Vesicle Therapy
iRegene Therapeutics
Cell Therapy Product Developer
Recently, Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, in collaboration with iRegene, launched the world's first clinical study on chemically induced cell-derived extracellular vesicle product NouvSoma001.After rigorous preliminary preparations, Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology successfully launched the "Exploratory Clinical Study Evaluating the Safety and Efficacy of NouvSoma001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders." The project successfully passed the review by the Ethics Committee of Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, obtained ethical approval, and recently held a successful clinical trial initiation meeting. This project is led by Professor Wang Wei, Standing Committee Member of the Party Committee, Executive Vice President of Huazhong University of Science and Technology, and Party Secretary of Tongji Hospital, in collaboration with Professor Tian Daishi from the Department of Neurology. It is an open-label, placebo-controlled, single-center clinical study evaluating the safety, tolerability, and efficacy of intrathecal injection of extracellular vesicles in patients with neuromyelitis optica spectrum disorders.
This clinical trial focuses on Neuromyelitis Optica Spectrum Disorder (NMOSD), an immune-mediated inflammatory demyelinating disease of the central nervous system. As the patient's immune system attacks the optic nerves and spinal cord, NMOSD is clinically characterized by optic neuritis, longitudinally extensive transverse myelitis, area postrema syndrome, brainstem syndrome, diencephalic syndrome, and cerebral syndrome, ultimately leading to vision loss and paralysis. NMOSD can be treated with corticosteroids (e.g., methylprednisolone) and immunosuppressive drugs, but there is currently no cure. This project utilizes NouvSoma001, a chemically induced cell-derived extracellular vesicle product, for the treatment of NMOSD, representing an active exploration into a novel therapy for this immune-mediated inflammatory demyelinating disease of the central nervous system.
Also launched synchronously this time is the "Exploratory Clinical Study Evaluating the Safety and Efficacy of NouvSoma001 Injection in the Treatment of Ischemic Stroke" conducted by the same research team. This project involves an open, placebo-controlled, single-center clinical study on the safety, tolerability, and efficacy of intravenous administration in patients with ischemic stroke. Ischemic stroke refers to sudden neurological deficits caused by localized cerebral ischemia and permanent cerebral infarction (e.g., positive findings on DWI examination). The research team has systematically and rigorously explored the mechanisms of NouvSoma001, a chemically induced cell-derived extracellular vesicle product, in ischemic stroke. Additionally, the intravenous injection of extracellular vesicles represents a novel and potentially safer treatment approach for ischemic stroke.
The teams participating in this clinical trial kick-off meeting include Professor Wang Wei, Professor Tian Daishi, Associate Professor Qin Chuan, Chief Physician Shang Ke, Deputy Chief Physician Xiao Jun from Tongji Hospital affiliated with Huazhong University of Science and Technology, as well as Dr. Cai Meng (CMO), Dr. Wei Jun (CEO), and Dr. Yan Ruorong (R&D Vice President) from iRegene. During the meeting, representatives thoroughly discussed the background, protocol, operational details, and risk contingency plans for this clinical trial. Leveraging the profound academic expertise in neuroimmunology, superior clinical resources, and rigorous clinical trial system of Professor Wang Wei, Professor Tian Daishi, and Associate Professor Qin Chuan’s team from Tongji Hospital affiliated with Huazhong University of Science and Technology, the implementation of this project is ensured.
NouvSoma001 Injection is a chemically induced extracellular vesicle product fully independently developed by iRegene Therapeutics Co., Ltd. (iRegene) using its existing mature technology platform. Systematic preclinical studies have preliminarily demonstrated the safety and efficacy of this product in primate models, laying the foundation for its clinical application and supporting its clinical feasibility. These two investigator-initiated clinical trials also mark iRegene's official entry into the era of cell-derived products.