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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Neo-Urinary Conduit

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Medical Institutions
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: NUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural integrity and conduit patency	CT scan will be used to demonstrate that urine is able to flow safety through the NUC	12 months post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural integrity and conduit patency	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	month 12 through month 60 post implantation
Procedure and/or product related AEs	procedure and/or product related AEs will be evaluated through month 60 post implantation	month 12 through month 60 post implant
Overall safety	overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters	from enrollment through month 60 post implant
Procedure and/or product related adverse events post implantation	Evaluation of procedure and/or product related adverse events	through 12 months post implantation

Collaborators and Investigators

• Sponsor: Tengion
• Investigators: Principal Investigator: Gary Steinberg, MD, University of Chicago; Principal Investigator: Trinity J Bivalacqua, M.D., Ph.D., The Johns Hopkins Medical Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimate): March 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: bladder cancer; radical cystectomy; incontinent urinary diversion
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: TNG-CL009