Tengion, a company out of East Norriton, PA, has successfully grown full size replacement bladders in large mammal models, helping pave the way for the company to receive FDA clearance to initiate clinical trials on humans in 2009. The company says that the results from a preclinical trial show that its product, known as Tengion Neo-Bladder Replacement™, is structurally similar to native bladders by six months.
Here’s what the company says in its press release about the long term morphology and performance of Tengion Neo-Bladder Replacement™:
The preclinical study presented at AUA [the Annual Meeting of the American Urological Association (AUA) in Orlando, Florida –ed.] 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.
Study results show that:
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