STOCKHOLM, SWEDEN (UroToday.com) - Dr. Trinity J. Bivalacqua from the Brady Urological Institute, Baltimore, reported on phase 1, multi-institutional, clinical study of the neo−urinary conduit (NUC), which, for the first time, demonstrated urinary tissue regenerative outcomes in humans.
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Briefly, NUC is produced by seeding an autologous population of adipose-sourced smooth muscle cells (SMC) onto a biodegradable PLGA scaffold. NUC is developed as a potential alternative to the use of intestine for urinary diversion after radical cystectomy. In this study, they provided a macroscopic and histological assessment of results from animal studies showing the regenerative outcomes of the NUC and compared these results to the results from conduits explanted 7 weeks and 10 months post-implantation from two patients enrolled into the study.
Presented data showed that regenerated tissue 3 months after implantation in the porcine model demonstrated formation of urinary tissue containing all layers of the genitourinary tract. Seven weeks post implantation, human explant showed evidence of early stages of urinary tissue. Urothelium (CK7+) and epithelium (cytokeratin AE1/AE3) was observed throughout the NUC, followed by non−layered smooth muscle cells (calponin) in the remaining body of the NUC. Data showed that at 10 months post-implantation, a mature organ composed of urinary tissue was obtained. Urothelium and tunica muscularis layer was fully developed and characterized by the presence of layered smooth muscle bundles surrounded by a fibrovascular stroma of the regenerated conduit’s wall. They also demonstrated presence of innervation (neurofilament 160) of the NUC from the native ureters.
Although results of translation of technology from animal model was demonstrated in this phase 1 clinical study, the development of a clinically functional urinary conduit remains to be proven. Further results of this ongoing multi-center phase 1 clinical trial should shine more light on this over the next few years.
Presented by Trinity J. Bivalacqua, MD, PhD at the 29th Annual European Association of Urology (EAU) Congress - April 11 - 15, 2014 - Stockholmsmässan - Stockholm, Sweden.
The James Buchanan Brady Urological Institute, Baltimore USA
Written by Reza Mehrazin, MD, medical writer for UroToday.com
EAU 2014, neo−urinary conduit (NUC), smooth muscle cells (SMCs)