Objective measurements of cochlear health using a cochlear implant: towards a biological therapy for hearing loss

世界卫生组织报告说，耳聋是导致残疾的第二大原因。世界上有5亿人患有致残性听力损失，导致巨大的个人，社会和经济困难。听力损失的治疗目前的标准是听力设备，包括助听器和人工耳蜗植入。然而，这些设备并没有解决潜在的问题：对内耳的损伤。目前，没有治疗听力损失的方法。Rinri Therapeutics正在开发一种新的治疗方法，“Rincell-1”，这是一种细胞疗法，有可能取代内耳中死亡或受损的神经细胞并恢复听力。为了进行临床试验，Rinri需要制定这种治疗的安全性和有效性的措施。据建议，Rincell-1的首次人体试验将与人工耳蜗植入相结合（目前对不再受益于助听器的聋人的治疗），因为这些植入物有能力远程监测内耳健康，因此，在临床试验中评估治疗的安全性和有效性。Rinri一直在与全球领先的听力研究机构合作，的诺丁汉开发必要的测量工具和手术技术，以进行Rincell-1的临床试验。我们请求提供资金，将在诺丁汉大学工作的听力学家和临床合格科学家Faizah Mushtaq博士借调到Rinri，以管理和加速这些工具和技术的开发和交付。这一借调将证明直接有利于Faizah，Rinri，诺丁汉大学和听力损失科学界。具体而言，Faizah将了解在行业环境中开发临床试验所需的流程。沿着她现有的临床和研究技能，这将为她提供听力领域几乎独一无二的技能，未来可应用于其他新型听力疗法的开发，这是解决全球听力损失负担所迫切需要的。同样，Rinri将从Faizah在临床和研究环境中监测听力健康的广泛知识中获益，沿着她对听力科学家和临床医生，听力设备行业以及Rincell-1的目标人群的独特理解：听力损失患者。最终，这一借调将加强Rinri和诺丁汉大学之间的思想交流，以开发一种革命性的新听力损失治疗方法。

The World Health Organisation reports deafness as the second leading cause of years lived with disability. Half a billion people in the world have disabling hearing loss resulting in enormous personal, social and economic hardship. The current standard of care for hearing loss are hearing devices, including hearing aids and cochlear implants. However, these devices do not address the underlying problem: damage to the inner ear. Currently, no treatments for hearing loss exist. Rinri Therapeutics is developing a new treatment, 'Rincell-1', a cell therapy with the potential to replace dead or damaged nerve cells in the inner ear and restore hearing. In order to conduct clinical trials, Rinri needs to develop measures of safety and effectiveness of this treatment. It is proposed that the first-in-human trials of Rincell-1 will be in combination with a cochlear implant (the current treatment for deaf people who no longer benefit from a hearing aid) as these implants have the capacity to remotely monitor inner ear health and, therefore, to assess the safety and effectiveness of a therapy in a clinical trial.Rinri have been working with global leaders in hearing research based at the University of Nottingham to develop the necessary measurement tools and surgical techniques to conduct a clinical trial of Rincell-1\. We request funds for the secondment of Dr. Faizah Mushtaq, an audiologist and clinically qualified scientist working at the University of Nottingham, to Rinri, in order to manage and accelerate the development and delivery of these tools and techniques. This secondment will prove directly beneficial to Faizah, Rinri, the University of Nottingham and the hearing loss scientific community. Specifically, Faizah will learn about the processes necessary to develop a clinical trial within an industry setting. Along with her existing clinical and research skills, this will provide her with an almost unique skillset in the hearing field that could be applied to the development of other novel hearing therapies in the future, which are desperately needed to address the global burden of hearing loss. Likewise, Rinri will gain from Faizah's extensive knowledge of monitoring hearing health in clinical and research settings, along with her unique understanding of hearing scientists and clinicians, the hearing device industry, and Rincell-1's target population: people with hearing loss. Ultimately, this secondment will enhance the exchange of ideas between Rinri and the University of Nottingham towards the development of a revolutionary new treatment for hearing loss.