Organ Regeneration Platform Restores Entire Urinary Bladder

For Neo-Bladder replacement, urothelial and smooth muscle cell are isolated from a full thickness biopsy of the patient's bladder, and are cultured for several weeks until there is a sufficient quantity; the cells are then meshed with a biodegradable scaffold and are monitored to make sure they grow properly and in the correct position within the platform. After eight weeks, the neo-bladder is ready for implantation. The biodegradable platform slowly dissolves, leaving the patient with a fully formed neo-bladder.

The preclinical study presented was a six-month, single-arm study to evaluate the applications of the technology. Neo-Bladder replacements were produced and were then surgically implanted into 23 large mammals. The study found that the regenerated bladder wall structure consisted of three layers: urothelium, muscle, and serosa by approximately two months after implantation, and the regenerated bladder wall showed near native pharmacological and electrophysiological functional responses by six months after implantation. The regenerated bladder also demonstrated near-baseline capacity and cystography by six months after implantation. The preclinical study data were presented at the annual meeting of the American Urological Association (AUA), held during May 2008 in Orlando (FL, USA). The Tengion Neo-Bladder Replacement is under development by Tengion (East Norriton, PA, USA).

"In this well-established preclinical model, the Neo-Bladder Replacement was able to achieve functional recovery and a regenerative response that emulated the native bladder,” said Tim Bertram, D.V.M., Ph.D., senior vice president of science and technology of Tengion. "These data join the existing body of information from the preclinical studies of our first product candidate, the Tengion Neo-Bladder Augment, and underscore the promise and potential of our autologous organ regeneration platform as a foundation for our pipeline of regenerative medicine products.”

Tengion is currently conducting a GLP (good laboratory practice) study of its Neo-Bladder Replacement to support a planned request to the U.S. Food and Drug Administration (FDA) 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 United States; 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 (OAB) and urge incontinence.


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