/ Not yet recruiting临床1/2期 First In Human, Multicentre, Open-Label Randomised Trial to Assess the Safety of Rincell-1 Otic Neural Progenitor Cell-Based Therapy in Addition to Standard Care, Compared With Standard Care Alone, in Participants With Presbycusis or Postsynaptic Auditory Neuropathy Who Meet UK Guidelines for Cochlear Implantation
Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also meet criteria for a cochlear implant. The goals of this study are:
* To learn about the safety profile of Rincell-1, the procedure used to inject it and the medications given to promote the growth of the cells
* To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons.
* To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery
Participants will be randomly assigned to one of two groups: one group that receives a standard care cochlear implant, and the other that will receive an injection of Rincell-1 at the same time as their standard care cochlear implant. Researchers will compare the safety of Rincell-1 in combination with a cochlear implant to a cochlear implant on its own.
Participants will take part in the trial for 52 weeks after CI surgery. During that time, they will have regular follow-ups and will take daily measurements at home of their hearing health.
100 项与 Rincell-1 相关的专利(医药)