A prospective, multi-center, open-label, single-arm phase 2b study of autologous adult live cultured buccal epithelial cells (AALBEC) in the treatment of bulbar urethral stricture.

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of autologous adult live cultured buccal epithelial cells (AALBEC) in treatment and management of bulbar urethral stricture in men. METHODS: This was a prospective, multi-center, open-label, single-arm phase 2b study. A total of 18 male patients with bulbar urethral stricture of at least 1 - 4 cm in length were enrolled in the study. All 16 patients had AALBEC implanted and were included in the safety set. Change in total American Urology Association (AUA) symptom score, urinary flow rates assessed by uroflowmetry and a requirement for surgery after 24 weeks from baseline were determined in patients. Data of treatment efficacy were analyzed. RESULTS: The AUA score at baseline was 21 (3.9) that showed a statistically significant reduction starting from week 2 [8 (4.4), p = 0.0001] which sustained until week 24 [2 (1.2), p = 0.0005]. Overall mean total AUA symptom score was reduced by 90.5% after the treatment. Significant reductions from baseline at week-24 were also observed in voiding time (92.5 (47.3) vs. 51.9 (17.4) s, p = 0.0046) and flow time [86.9 (48.2) vs. 47.9 (19.6) s, p = 0.0052]. All patients showed absence of any significant adverse events. CONCLUSION: Significant improvement was seen in the AUA symptom score and uroflowmetry parameters and no patients required surgery during 24 weeks post-treatment. It can be concluded that AALBEC is a safe and effective treatment for bulbar urethral stricture of 1 - 4 cm length to improve the quality of life and the physiological function of urethra.