Regenerative Therapy for Hearing Loss

(HEAR-RESTORE Trial)

This trial explores new treatments for individuals with hearing issues such as hearing loss, tinnitus (ringing in the ears), or inner ear injuries. The researchers aim to understand the development of these problems and test therapies that might restore hearing or protect the ear. Participants will undergo various hearing evaluations and may receive treatments like regenerative medicines, stem cell therapies, or a combination of different approaches, known as Combination Regenerative Therapy. Individuals with sensorineural hearing loss or tinnitus, who have difficulty hearing at certain frequencies, might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive potentially groundbreaking therapies.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

In a previous study, researchers examined the safety of new treatments for hearing loss that help regrow hair cells in the ear. Hair cells are crucial for hearing. The study found minimal side effects, and patients tolerated the treatment well. Another study demonstrated noticeable improvements in hearing without major safety issues.

For stem cell therapies, researchers have used these treatments to restore natural hearing. In these studies, most participants did not report serious side effects, indicating that these therapies are generally safe. Participants also experienced better hearing and sound recognition, showing the treatment's safety and effectiveness.

Studies on combination therapies using both drug and stem cell methods have shown promising results. Participants experienced measurable improvements in hearing, and safety checks confirmed the treatments were well-tolerated. This combined approach aims to maximize benefits while minimizing risks.

Researchers are excited about the regenerative therapies for hearing loss because these treatments aim to repair and regenerate the damaged structures of the inner ear, which is a novel approach compared to the standard hearing aids and cochlear implants that merely assist with hearing. The investigational pharmacologic therapy supports the recovery of cochlear hair cells, potentially preventing further damage. Meanwhile, the stem cell therapy targets the restoration of inner ear structures and auditory nerve pathways, offering a cellular-level repair. The combination therapy uniquely integrates both pharmacologic and biological methods, aiming for a comprehensive auditory recovery. This regenerative approach could lead to groundbreaking improvements in hearing restoration, offering hope for more effective, long-lasting solutions.

This trial will compare different regenerative therapies for hearing loss. Participants in the Regenerative Pharmacologic Therapy arm will receive investigational pharmacologic therapies designed to support inner ear recovery. Meanwhile, those in the Stem Cell Investigational Therapy arm will receive stem cell-based approaches intended to repair inner ear structures. The Combination Regenerative Therapy arm will explore a mix of regenerative strategies, potentially including pharmacologic agents combined with biological or cellular therapies. Research has shown that new treatments aimed at repairing the inner ear are promising. For example, gene therapy has helped 90% of patients with inherited deafness hear better, with some achieving almost normal hearing. Scientists are also investigating the use of stem cells to fix or regrow damaged hearing cells. Some studies have found that using special inner ear cells can partially restore hearing. Combining gene therapy and stem cell treatment has also shown potential benefits, with some patients experiencing significant hearing improvements, gaining 10 decibels or more.²⁴⁵⁶⁷