Abstract
Background: Radiation-induced skin injury (RSI) affects 85-90\% of radiotherapy patients, with limited effective treatment options available. A recent Phase II randomized controlled trial investigated the efficacy of placental mesenchymal stem cell (PMSC)-embedded alginate hydrogel for treating moderate-to-severe RSI.
Methods: This commentary analyzes the double-blinded, placebo-controlled trial by Tian et al. (N= 66), which evaluated once-daily PMSC hydrogel application (1× viable PMSCs) for six days in patients with grade II or higher RSI. Primary endpoints included overall recovery rate, wound regression, and dermatitis severity scores.
Results: The PMSC hydrogel group demonstrated statistically significant improvement in healing rates (p ˂ 0.001), with 64% relative risk reduction in wound progression compared to placebo. Radiation-Induced Skin Reaction Assessment Scale scores and pain relief showed significant benefits by Day 6. TGF-β1 biomarker elevation suggested native tissue repair mechanisms. No serious adverse events were reported during the study period. Key constraints include a single-center design, a small sample size, a 15-day follow-up duration, the absence of quality-of-life improvements on the EORTC QLQ-C30, and the lack of reported cancer types or radiation regimen details, limiting generalizability.
Conclusion: The trial presents encouraging preliminary evidence supporting PMSC hydrogel’s potential in accelerating the RSI healing process. However, definitive conclusions regarding practice-change efficacy require confirmation through larger, multicenter Phase III trials with extended follow-up (3-6 months), comprehensive patient-centered outcomes, cost-effectiveness analysis, and through assessment of late effects, including fibrosis.
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Copyright (c) 2025 Fatma A. Rikabe, Abdelrhman Gouda, Abdelrhman H. Mohamed, Sampana Fatima (Author)