The preclinical trial was a six-month, single-arm study to evaluate the application of Tengion’s technology to regenerate an entire urinary bladder. Neo-Bladder Replacements were produced from autologous bladder cells seeded onto a biodegradable scaffold and were then surgically implanted into 23 large mammals.
In this study, Tengion’s Neo-Bladder Replacement was able to regenerate an entire urinary bladder within six months after implantation. The regenerated bladder demonstrated near-baseline capacity and cystography by six months after implantation. The regenerated bladder wall structure consisted of three layers – urothelium, muscle, and serosa by approximately two months after Implantation. The regenerated bladder wall showed near native pharmacological and electrophysiological functional responses by six months after implantation.
Tengion is currently conducting a GLP study of its Neo-Bladder Replacement to support a planned request to the FDA in the near future to initiate human clinical trials in 2009. Additionally, Tengion is currently conducting three Phase II clinical trials of its Neo-Bladder Augment at 12 academic medical centers across the US – one in children with neurogenic bladder due to spina bifida, one in adults with neurogenic bladder due to spinal cord injury and one in adult patients with overactive bladder and urge incontinence.