2026-07-01 | Intratympanic injection of human umbilical cord mesenchymal stem cell derived small extracellular vesicles for refractory sudden sensorineural hearing loss: a Phase 1 trial.
Refractory sudden sensorineural hearing loss (RSSNHL) remains a therapeutic challenge with limited effective treatment options. Human umbilical cord mesenchymal stem cell-derived small extracellular vesicles (hucMSC-sEVs) have demonstrated otoprotective and regenerative potential in preclinical studies. This Phase 1 trial evaluated the safety of intratympanic hucMSC-sEVs in patients with RSSNHL. This single-center, open-label, single-arm clinical study enrolled RSSNHL patients between June and September 2025 (ChiCTR2500103765). Participants received intratympanic hucMSC-sEVs for five consecutive days across four dose cohorts, ranging from 8 × 10⁸ to 1 × 10¹¹ particles/mL. Follow-up assessments were conducted at 1, 2, 4, and 8 weeks after treatment, during which adverse events (AEs) were recorded, and hearing outcomes were evaluated. Twelve of the thirteen enrolled patients completed the 8-week follow-up. Intratympanic administration of hucMSC-sEVs was well tolerated across all dose levels, with no dose-limited toxicity or serious AEs. The most common AEs were ear pain (5/12), ear fullness (3/12), and transient dizziness (2/12), all characteristic of intratympanic injection and resolving without intervention. In this Phase 1 study, intratympanic hucMSC-sEVs were well tolerated and showed preliminary signals of hearing improvement. Responses were observed only in patients receiving lower dose levels (8 × 10⁸ and 4 × 10⁹ particles/mL) and in those treated within a shorter disease window (≤ 22 days). These exploratory findings require confirmation in larger controlled trials. Trial Registration This study was registered on June 5,2025, at Chinese Clinical Trial Registry (ChiCTR2500103765).
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2026-06-25 | Management of Sensorineural Hearing Loss in Adults: Consideration of Lifestyle Practices from a Mitochondrial Perspective.
The physiological processes of sensorineural hearing in the cochlea have high energy demands. As energy is provided mainly by mitochondria housed in cochlear cells, mitochondrial dysfunction can possibly lead to sensorineural hearing loss (SNHL). Consequently, hearing benefits can potentially be derived if measures that can potentially enhance mitochondrial health are implemented. Unhealthy lifestyle practices have led to an increased risk of developing systemic oxidative stress and chronic inflammation. These, in turn, may result in persistent mitochondrial dysfunction in the body. Together, they could possibly lead to the development of SNHL and other non-communicable chronic diseases (NCDs). Factors such as micro-nutrient deficiencies, obstructive sleep apnea, and gut dysfunction could result in mitochondrial dysfunction. On the other hand, mitochondrial function could be enhanced by interventions such as better food choices and hormetic strategies like intermittent fasting. Conventional treatments of SNHL focus on steroid therapy in acute loss and hearing rehabilitation with hearing devices in chronic loss. By integrating personalized healthy lifestyle strategies, it is postulated that the chances of hearing recovery in acute SNHL could be enhanced in some patients. In chronic SNHL, they could help to prevent/slow down its progression and possibly also the progression of concomitant NCDs. Further research is warranted to substantiate these postulations.
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