Tengion’s product effective in restoring bladder function

The purpose of the preclinical study was to examine the structural and functional aspects of bladder regeneration in a well-established preclinical model.

Tengion’s Neo-Bladder Augment composed of a biodegradable scaffold and autologous urothelial and smooth muscle cells (neo-bladder group, n=32) was compared to re-implanted native bladder (re-implant group, n=32) and to biodegradable scaffold alone (scaffold group, n=8) at one, three, six and nine months post-implantation.

The study findings show that within 14 days, all 72 subjects were continent and within one month their acute phase responses, hematological and urinalysis parameters had returned to baseline. However, only the group receiving the Tengion Neo-Bladder Augment achieved functional recovery (urodynamics) and a regenerative tissue response that emulated the native bladder’s structure, function and biofeedback.

This neo-bladder group regained baseline bladder capacity by four months and compliance by six months. These findings were sustained throughout the study. In contrast, over time the re-implant group became unstable, with urodynamic parameters significantly lower than baseline by nine months (60-75% decrease from baseline).

Further, the re-implant and scaffold groups showed urodynamically decreased compliance at nine months that correlated histologically with limited healing and incomplete bladder wall regeneration. Finally, treatment-related morbidity was only observed in the re-implant and scaffold groups.