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Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tengion
ClinicalTrials.gov Identifier:
NCT01087697
First received: March 15, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Device: Neo-Urinary Conduit
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy

Resource links provided by NLM:


Further study details as provided by Tengion:

Primary Outcome Measures:
  • Structural integrity and conduit patency [ Time Frame: 12 months post implantation ] [ Designated as safety issue: Yes ]
    CT scan will be used to demonstrate that urine is able to flow safety through the NUC


Secondary Outcome Measures:
  • Structural integrity and conduit patency [ Time Frame: month 12 through month 60 post implantation ] [ Designated as safety issue: Yes ]
    CT scan and renal ultrasound will be used to demonstrate that urine is able to flow safely through the NUC through 60 months post implantation

  • Procedure and/or product related AEs [ Time Frame: month 12 through month 60 post implant ] [ Designated as safety issue: Yes ]
    procedure and/or product related AEs will be evaluated through month 60 post implantation

  • Overall safety [ Time Frame: from enrollment through month 60 post implant ] [ Designated as safety issue: Yes ]
    overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters

  • Procedure and/or product related adverse events post implantation [ Time Frame: through 12 months post implantation ] [ Designated as safety issue: Yes ]
    Evaluation of procedure and/or product related adverse events


Estimated Enrollment: 10
Study Start Date: March 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implanted with NUC
Patients who have been implanted with the Neo-Urinary Conduit
Device: Neo-Urinary Conduit
Implantation with the autologous Neo-Urinary Conduit
Other Name: NUC

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087697

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
The Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tengion
Investigators
Principal Investigator: Gary Steinberg, MD University of Chicago
Principal Investigator: Trinity J Bivalacqua, M.D., Ph.D. The Johns Hopkins Medical Institute
  More Information

No publications provided

Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT01087697     History of Changes
Other Study ID Numbers: TNG-CL009
Study First Received: March 15, 2010
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tengion:
bladder cancer
radical cystectomy
incontinent urinary diversion

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014