Clinical interventions in aging · 2026
Short-Term Audiometric Trajectories in Older Adults Receiving Systemic Human Umbilical Cord-Derived Mesenchymal Stem Cells: An Exploratory Single-Arm Substudy.
Клинический случайКлиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Song Mengtao, Kong Xiaoxuan, Wang Dayong, Chen Guohui, Li Jin, Zhang Jiao, Yan Jin, Hou Xiaoqiang, Cao Feng, Wang Qiuju
Аннотация
PURPOSE: To describe short-term longitudinal audiologic outcomes after systemic administration of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in older adults with vascular aging.
PATIENTS AND METHODS: This exploratory, single-arm audiologic substudy was embedded within a nonrandomized interventional parent trial of hUC-MSC administration for vascular aging. Participants were aged 60 to 80 years and met the parent study's prespecified eligibility criteria. Audiometric outcomes were assessed repeatedly at baseline and on days 30, 90, and 180 after the first infusion. The primary exploratory audiologic outcome was the ear-level change from baseline to day 90 in the 4-frequency pure-tone average (PTA-4; 0.5, 1, 2, and 4 kHz), with negative values indicating lower hearing thresholds at follow-up. Mean changes were estimated using a linear mixed-effects model for repeated measures.
RESULTS: Of 107 treated participants, 93 entered the hearing substudy (47 men [50.5%] and 46 women [49.5%]; mean [SD] age, 68.7 [5.1] years). After ear-level exclusions, 176 eligible ears from 91 participants comprised the analysis set. At day 90, 156 ears from 81 participants were evaluable. The model-estimated mean change in PTA-4 from baseline to day 90 was -0.77 dB HL (95% CI, -1.52 to -0.02). Among evaluable ears, the observed mean change from baseline to day 90 was -0.75 dB HL (95% CI, -1.52 to 0.02). Both estimates were less than 1 dB in magnitude and small relative to reported short-term audiometric test-retest variability. At days 30, 90, and 180, 97.2%, 95.5%, and 96.3% of evaluable ears, respectively, remained within the prespecified ±10-dB stability range.
CONCLUSION: In this exploratory single-arm substudy, mean PTA-4 changed little over short-term follow-up, and most evaluable ears remained within the prespecified stability range. Without a concurrent audiologic comparator, the observed trajectory cannot be attributed causally to hUC-MSC administration. These data may inform future controlled studies.
PARENT TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2500101200; registered on April 22, 2025.
PATIENTS AND METHODS: This exploratory, single-arm audiologic substudy was embedded within a nonrandomized interventional parent trial of hUC-MSC administration for vascular aging. Participants were aged 60 to 80 years and met the parent study's prespecified eligibility criteria. Audiometric outcomes were assessed repeatedly at baseline and on days 30, 90, and 180 after the first infusion. The primary exploratory audiologic outcome was the ear-level change from baseline to day 90 in the 4-frequency pure-tone average (PTA-4; 0.5, 1, 2, and 4 kHz), with negative values indicating lower hearing thresholds at follow-up. Mean changes were estimated using a linear mixed-effects model for repeated measures.
RESULTS: Of 107 treated participants, 93 entered the hearing substudy (47 men [50.5%] and 46 women [49.5%]; mean [SD] age, 68.7 [5.1] years). After ear-level exclusions, 176 eligible ears from 91 participants comprised the analysis set. At day 90, 156 ears from 81 participants were evaluable. The model-estimated mean change in PTA-4 from baseline to day 90 was -0.77 dB HL (95% CI, -1.52 to -0.02). Among evaluable ears, the observed mean change from baseline to day 90 was -0.75 dB HL (95% CI, -1.52 to 0.02). Both estimates were less than 1 dB in magnitude and small relative to reported short-term audiometric test-retest variability. At days 30, 90, and 180, 97.2%, 95.5%, and 96.3% of evaluable ears, respectively, remained within the prespecified ±10-dB stability range.
CONCLUSION: In this exploratory single-arm substudy, mean PTA-4 changed little over short-term follow-up, and most evaluable ears remained within the prespecified stability range. Without a concurrent audiologic comparator, the observed trajectory cannot be attributed causally to hUC-MSC administration. These data may inform future controlled studies.
PARENT TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2500101200; registered on April 22, 2025.