Short-Term Audiometric Trajectories in Older Adults Receiving Systemic Human Umbilical Cord-Derived Mesenchymal Stem Cells: An Exploratory Single-Arm Substudy

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.