接受全身性人脐带来源间充质干细胞的老年人的短期听力轨迹：一项探索性单臂子研究
Short-Term Audiometric Trajectories in Older Adults Receiving Systemic Human Umbilical Cord-Derived Mesenchymal Stem Cells: An Exploratory Single-Arm Substudy.
文献信息
| PMID | 42819495 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Mengtao Song |
| 作者单位 | Department of Audio-Vestibular Medicine, Senior Department of Otolaryngology-Head and Neck Surgery, The Sixth Medical Center of Chinese PLA General Hospital, Beijing, 100048, People's Republic of China. |
| 期刊 | Clinical interventions in aging |
| SCI 分区 | Q2 |
| IF | 4.5 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 描述血管衰老老年人全身给予人脐带来源间充质干细胞（hUC-MSCs）后的短期纵向听力学结局。
患者与方法： 这项探索性、单臂听力学子研究嵌套于一项针对血管衰老给予hUC-MSC的非随机干预性母试验中。参与者年龄为60至80岁，并符合母研究预先设定的入选标准。在基线和首次输注后第30、90和180天重复评估听力学结局。主要探索性听力学结局为从基线至第90天耳水平4频率纯音平均（PTA-4；0.5、1、2和4 kHz）的变化，负值表示随访时听力阈值更低。平均变化采用重复测量线性混合效应模型估计。
结果： 107名接受治疗的参与者中，93名进入听力子研究（47名男性[50.5%]和46名女性[49.5%]；平均[SD]年龄，68.7[5.1]岁）。排除耳水平不合格者后，来自91名参与者的176只合格耳构成分析集。第90天时，来自81名参与者的156只耳可评估。模型估计的PTA-4从基线至第90天的平均变化为-0.77 dB HL（95% CI，-1.52至-0.02）。在可评估耳中，观察到的从基线至第90天平均变化为-0.75 dB HL（95% CI，-1.52至0.02）。两项估计的幅度均小于1 dB，相对于已报道的短期听力测试-重测变异性而言较小。在第30、90和180天，分别有97.2%、95.5%和96.3%的可评估耳仍处于预先设定的±10-dB稳定性范围内。
结论： 在这项探索性单臂子研究中，平均PTA-4在短期随访中变化很小，大多数可评估耳仍处于预先设定的稳定性范围内。由于没有同期听力学对照，观察到的轨迹不能因果归因于hUC-MSC给药。这些数据可能为未来的对照研究提供信息。
母试验注册： 中国临床试验注册中心标识符：ChiCTR2500101200；注册于2025年4月22日。
英文摘要
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.