Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss

Condition(s) studied

Investigational drug(s) / intervention(s)

Audiologic Monitoring: Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.

Investigational Regenerative Pharmacologic Therapy: Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.

Stem Cell Regenerative Therapy: Investigational regenerative therapy involving stem cell-based approaches intended to support repair of cochlear hair cells and auditory neural pathways.

Combination Regenerative Therapy: Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.

Study summary

The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. Inner ear disorders can result from acoustic trauma, infections, inflammation, or other conditions that affect the cochlea, auditory nerve, or vestibular system. These conditions may lead to muffled hearing, ringing in the ears (tinnitus), balance disturbances, or reduced hearing sensitivity.

The purpose of this study is to better understand how inner ear injuries develop and to evaluate potential treatments that may support hearing recovery or protect auditory function. Participants will undergo comprehensive ear and hearing evaluations including audiometry, speech recognition testing, tympanometry, and other diagnostic assessments used in audiology and otolaryngology. These tests help measure hearing thresholds, ear pressure, and auditory nerve responses.

The study may also explore emerging regenerative medicine strategies aimed at restoring inner ear function. These approaches may include investigational therapies designed to promote repair of cochlear hair cells, reduce inflammation in the inner ear, or support neural recovery in the auditory pathway. Research may include evaluation of regenerative biological therapies, stem cell-based approaches, and other experimental technologies intended to support recovery of hearing or reduce symptoms such as tinnitus.

Participants will be monitored over time to assess hearing outcomes, safety, and changes in auditory function. Study assessments may include repeat audiology tests, imaging studies, symptom questionnaires, and other clinical measurements used to track hearing health.

The results of this research may contribute to improved diagnostic methods and potential future treatments for individuals with hearing loss or inner ear disorders.

Eligibility

Primary outcome measure(s)

• Change in Pure-Tone Audiometry Hearing Threshold (dB HL) — Baseline to 6 months
  Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.

Trial sites (1)