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Clinical Trial Update: Tengion accelerates, expands stem cell-based urinary conduit trial

The Neo-Urinary Conduit™ combines a patient's own cells and a bio-absorbable scaffold to regenerate a native-like urinary tissue conduit, transporting urine through a hole in the abdomen into a standard ostomy bag. Urinary conduits are often constructed from bowel tissue, which puts patients at risk for complications associated with the bowel tissue as well as the surgery needed to harvest it.

The Neo-Urinary Conduit is the only product candidate currently in development that aims to avoid the use of bowel tissue, the company says. The trial was designed to assess its safety and preliminary efficacy as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients.

Following a positive meeting with the Data Safety Monitoring Board, Tengion is proceeding with enrolling the next two patients in the clinical trial with the goal of completing implantation in up to 10 patients by year's end.

The company also announced that the trial is being expanded to four more sites. In addition to University of Chicago Medical Center and The Johns Hopkins Hospital in Baltimore, surgeons will be trained on the implantation procedure at Memorial Sloan-Kettering Cancer Center in New York; Baylor Charles A. Sammons Cancer Center in Dallas; University of Michigan Comprehensive Cancer Center in Ann Arbor, Mich.; and a fourth site in Boston.

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