Tengion, a clinical stage biotechnology company focused on the development of neo-organs and neo-vessels has initiated its third Phase 2 multi-center clinical trial of its Neo-Bladder Augment derived from a patient's own (autologous) cells.

Tengion, a clinical stage biotechnology company focused on the development of neo-organs and neo-vessels has initiated its third Phase 2 multi-center clinical trial of its Neo-Bladder Augment derived from a patient's own (autologous) cells.

The U.S.-based study is being conducted at five hospitals in 10 adult patients with non-neurogenic over-active bladder (OAB) who are intolerant or not adequately responsive to medical therapy.

A variety of pharmacotherapy options have been tried in the treatment of OAB, with varying degrees of success and tolerability. In the absence of either symptom improvement or ability to tolerate pharmacotherapy, more aggressive measures may be utilized, including the investigational injection of botulism toxin (e.g., Botox, Allergan), neurostimulation (e.g., InterStim, Medtronic) or surgical intervention. Surgery in this population is generally reserved for when all other therapeutic interventions have failed. The goal of surgery is to increase the functional capacity of the bladder with a view toward symptomatic and quality of life improvement.

This new Phase 2 clinical trial in adults with non-neurogenic OAB and urge predominant incontinence is an open-label, prospective, single-study group trial. Patients will undergo a small bladder biopsy to collect autologous urinary bladder smooth muscle and urothelial cells. At Tengion's state-of-the-art manufacturing facility, each Neo-Bladder Augment will be constructed using the patient's healthy cells from the biopsy. After approximately four to eight weeks, expanded cells will be seeded on a biodegradable scaffold to produce the Neo-Bladder Augment. Approximately one week later, a surgeon will surgically implant the Neo-Bladder Augment back into the patient's native bladder during an augmentation cystoplasty procedure

This Phase 2 clinical trial in adults with OAB and urge incontinence is the third Phase 2 trial initiated since January 2007 to assess the safety and efficacy of the Tengion Neo-Bladder Augment(TM) in a range of patients suffering from various forms of bladder failure and impairment.