Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:5/3/2014
Start Date:March 2010
End Date:September 2017
Contact:William S Aronstein, PhD, MD
Email:baronstein@ctifacts.com
Phone:513 598-9290

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A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy

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.

The NUC under investigation is a regenerative medicine product comprised of the patient's
own smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate
culture conditions to reproducibly generate the necessary quantities of SMC in vitro from
autologous adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing
Practices (GMP) qualified clinical production facility. In this process, smooth muscle cells
(SMC) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4
weeks. At the end of this process, the SMCs are seeded onto the surface of a biodegradable
PGA/PLGA mesh scaffold to form the NUC. The NUC is shipped to the investigative site for
surgical implantation. Over time, the NUC should facilitate the regeneration of urinary
tract tissue.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
6
sites
Baltimore, Maryland 21287
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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New York, NY
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Ann Arbor, MI
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