Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

This study is currently recruiting participants.
Verified April 2013 by Tengion
Sponsor:
Information provided by (Responsible Party):
Tengion
ClinicalTrials.gov Identifier:
NCT01087697
First received: March 15, 2010
Last updated: May 2, 2013
Last verified: April 2013

March 15, 2010
May 2, 2013
March 2010
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01087697 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
Device: Neo-Urinary Conduit
Implantation with the autologous Neo-Urinary Conduit
Other Name: NUC
Experimental: Implanted with NUC
Patients who have been implanted with the Neo-Urinary Conduit
Intervention: Device: Neo-Urinary Conduit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2017
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: William S Aronstein, PhD, MD 513 598-9290 baronstein@ctifacts.com
Contact: Brian C Johnston 513 598-9290 bjohnston@ctifacts.com
United States
 
NCT01087697
TNG-CL009
Yes
Tengion
Tengion
Not Provided
Principal Investigator: Gary Steinberg, MD University of Chicago
Principal Investigator: Trinity J Bivalacqua, M.D., Ph.D. The Johns Hopkins Medical Institute
Tengion
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP