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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


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Structural integrity and conduit patency

Outcome Description:

CT scan will be used to demonstrate that urine is able to flow safety through the NUC

Outcome Time Frame:

12 months post implantation

Safety Issue:

Yes

Principal Investigator

Gary Steinberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

TNG-CL009

NCT ID:

NCT01087697

Start Date:

March 2010

Completion Date:

September 2017

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • radical cystectomy
  • incontinent urinary diversion
  • Urinary Bladder Neoplasms

Name

Location
Baylor College of Medicine Houston, Texas  77030
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Brigham and Women's Hospital Boston, Massachusetts  02115
The University of Chicago Chicago, Illinois  60637
University of Michigan Health System Ann Arbor, Michigan  
The Johns Hopkins Medical Institutions Baltimore, Maryland  21287