ArticleWorld journal of urology2026
A first-in-human pilot study of Wharton's jelly-derived mesenchymal stem cell injection for urethral stricture: safety and preliminary efficacy.
Article in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundUrethral stricture is a fibrotic narrowing of the urethra with limited long-term success using minimally invasive treatments. Mesenchymal stem cells (MSCs) possess antifibrotic and regenerative properties that may offer a novel therapeutic approach. This first-in-human pilot study evaluated the safety and preliminary efficacy of Wharton’s jelly-derived MSC injections for recurrent bulbar urethral stricture.
methodsEleven men with recurrent bulbar urethral strictures ≤ 2 cm underwent urethral dilatation followed 3–5 days later by intralesional injection of 4 × 10^6 MSCs. MSCs were cryopreserved under ultra-low temperatures, transported at 2–8 °C on the day of injection, and viability (> 70%) was confirmed post-thaw. Patients were followed for six months, with assessments including uroflowmetry, post-void residual, urethroscopy or retrograde urethrography, and patient-reported outcomes (IPSS, IIEF, USS-PROM). Safety was monitored throughout.
resultsThe procedure was completed in all patients without technical difficulties. No systemic or long-term local adverse events were observed. Two patients experienced transient dysuria and one had minimal hematuria, all resolving spontaneously. Median Qmax improved from 8.9 mL/s preoperatively to 16.4 mL/s at 1 month but declined toward baseline by 6 months. Patient-reported outcomes showed short-term improvements, with significant reductions in IPSS and USS-PROM scores at 1 and 3 months. No statistically significant changes were observed in uroflowmetry parameters over the six-month follow-up.
conclusionsIntralesional injection of Wharton’s jelly-derived MSCs following urethral dilatation is safe and feasible in humans. While objective urinary flow improvements were limited, patient-reported symptoms showed short-term benefit. These findings support further investigation in larger, controlled trials to optimize dosing, evaluate repeated administration, and determine efficacy in urethral stricture management.
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