WORLD JOURNAL OF UROLOGY, cilt.44, sa.1, 2026 (SCI-Expanded, Scopus)
Background Urethral 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 therapeu-tic 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.
Methods Eleven 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 degrees C on the day of injection, and viability (>70%) was confirmed post-thaw. Patients were followed for six months, with assess-ments including uroflowmetry, post-void residual, urethroscopy or retrograde urethrography, and patient-reported outcomes (IPSS, IIEF, USS-PROM). Safety was monitored throughout
Results The 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 spontane-ously. 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.
Conclusions Intralesional 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.