Process and non-clinical development of a stem cell therapy for hearing loss

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Half a billion people in the world have disabling hearing loss resulting in enormous personal, social and economic hardship. The vast majority of hearing loss cases are produced by the loss of sensory hair cells and/or their associated neurons. Mammals in general, and humans in particular, do not have the ability to restore these cells. We are born with a complement of cells that should last a lifetime. When these are damaged, permanent deafness ensues. The current standard of care is based on hearing devices, such as hearing aids and cochlear implants. However, these devices do not address the underlying problem of cell loss. Currently, no treatments that can regenerate or restore cells exist for hearing loss.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 reach clinical trials, Rinri needs to adapt the methods to generate the relevant cells currently used in a research lab to an industrial standard that fulfils the stringent manufacture and safety regulations. Rinri have been working with its founder and creator of the original technology at the University of Sheffield, translating the research from the academic lab and making it compatible with a cell manufacture organization. We request funds for the secondment of Dr. Leila Abbas, a researcher with expertise in hearing loss and stem cell technology working at the University of Sheffield, to Rinri, in order to manage and accelerate the development of these industrial processes. This secondment will prove directly beneficial to Leila, Rinri, the University of Sheffield and the hearing loss scientific community. Specifically, Leila will learn about the strategies, challenges and regulations involved in the manufacture of a cell-drug product. Along with her existing research skills, this will provide her with an almost unique skillset in the biotech industry 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 Leila's extensive knowledge of the fundamental biology underpinning hearing and deafness, the behaviour of stem cells along with her unique understanding of hearing scientists 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 Sheffield towards the development of a revolutionary new treatment for hearing loss.