Abstract
Background Biomechanical stimulation promotes tissue regeneration and healing. Bladder regeneration is biomechanically stimulated by cycling (filling, storage and evacuation). Interruption of cycling in patients with neurogenic bladders leads to functional and structural alterations. Material and Methods Cycling impacts on bladder tissue regeneration in cystectomized animals implanted with cell-seeded PLGA-based scaffolds were evaluated and learnings applied to the Tengion Autologous Neo-Bladder Augment™ (NBA) Phase II clinical trial studying patients with neurogenic bladder due to spina bifida. Results Neo-bladder cycling was initiated in animals 2 weeks post-implantation for 3 days/week. Urodynamic assessments from three cycling cohorts were evaluated: HIGH (10 weeks, >3.75 hr/day, >60 hrs), LOW (10 weeks, Conclusions Early post-implantation cycling is essential for regenerative healing following implantation of autologous cell-seeded PLGA-based scaffolds in animals and humans. Insights from Preclinical studies are consistent with insights from a Phase II clinical trial of the Tengion Autologous Neo-Bladder Augment™ and confirm the importance of cycling in bladder regeneration.
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