For many bladder cancer patients who have their cancerous bladders removed, the current standard of care is the surgical creation of a urinary diversion using a segment of the patient’s own bowel tissue to carry urine from the kidneys to a plastic bag on the abdominal wall. Tengion’s Neo-Urinary Conduit is built from a patient’s own cells obtained from a fat biopsy. The product is designed to catalyze regeneration of native-like bladder tissue, eliminating the need to use bowel tissue as a replacement for the cancerous bladder. The Neo-Urinary Conduit is designed to avoid many of the complications associated with the use of bowel tissue. Complications most often associated with the current standard of care include bowel obstructions, bowel leakage, systemic absorption of urine via the bowel tissue, recurrent infections, stone formation, and mucus secretion in the urine.
The ongoing study, which initially will enroll up to five patients with bladder cancer following bladder removal, is designed to provide data on the safety profile for the Neo-Urinary Conduit as well as to optimize the surgical technique and the ideal post-surgical patient care before proceeding into larger trials. The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled.