The protocol for this initial clinical trial calls for each of the 1st few patient implantations to occur at least 8 weeks after the previous patient surgery.
- The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled but, no modifications to the protocol have been made based on the experience with the 1st patient.
This trial is evaluating Tengion’s Neo-Urinary Conduit in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy;
- The ongoing study 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 first 2 patients are being treated at the University of Chicago Medical Center by the principal investigator at the site for this study, Gary D. Steinberg, M.D., Professor of Surgery and Director, Urologic Oncology.
The trial is also being conducted at a 2nd clinical site at The Johns Hopkins Hospital in Baltimore, Maryland.
- Tengion expects to implant 5 patients by the middle of 2011 with scheduled 3 month clinical assessments on all patients expected to be completed in the 2nd half of 2011