Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

Completed · Phase 1

Conditions studied: Bladder Cancer

In brief

The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

Key facts

Study ID: NCT01087697
Run by: Tengion
People needed: 8
Starts: 2010-03-01
Expected to finish: 2014-12-01
Last updated by the study team: 2014-12-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female subjects 18 - 80 years of age
Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0
Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy

You may not qualify if…

History of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer)
Evidence of cancer metastasis
History of any pelvic radiation or non-pelvic radiation within past 5 years
Debilitating cardiac or pulmonary disease
Expected need for chemotherapy within 3 months post cystectomy
Life expectancy less than 2 years

Where it is running

The University of Chicago — Chicago, Illinois, United States
The Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
University of Michigan Health System — Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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