search
Back to results

Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neo-Urinary Conduit
Sponsored by
Tengion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, radical cystectomy, incontinent urinary diversion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago
  • The Johns Hopkins Medical Institutions
  • Brigham and Women's Hospital
  • University of Michigan Health System
  • Memorial Sloan-Kettering Cancer Center
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted with NUC

Arm Description

Patients who have been implanted with the Neo-Urinary Conduit

Outcomes

Primary Outcome Measures

Structural integrity and conduit patency
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
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
procedure and/or product related AEs will be evaluated through month 60 post implantation
Overall safety
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
Evaluation of procedure and/or product related adverse events

Full Information

First Posted
March 15, 2010
Last Updated
December 9, 2014
Sponsor
Tengion
search

1. Study Identification

Unique Protocol Identification Number
NCT01087697
Brief Title
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
Official Title
A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tengion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, radical cystectomy, incontinent urinary diversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implanted with NUC
Arm Type
Experimental
Arm Description
Patients who have been implanted with the Neo-Urinary Conduit
Intervention Type
Device
Intervention Name(s)
Neo-Urinary Conduit
Other Intervention Name(s)
NUC
Intervention Description
Implantation with the autologous Neo-Urinary Conduit
Primary Outcome Measure Information:
Title
Structural integrity and conduit patency
Description
CT scan will be used to demonstrate that urine is able to flow safety through the NUC
Time Frame
12 months post implantation
Secondary Outcome Measure Information:
Title
Structural integrity and conduit patency
Description
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
Time Frame
month 12 through month 60 post implantation
Title
Procedure and/or product related AEs
Description
procedure and/or product related AEs will be evaluated through month 60 post implantation
Time Frame
month 12 through month 60 post implant
Title
Overall safety
Description
overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters
Time Frame
from enrollment through month 60 post implant
Title
Procedure and/or product related adverse events post implantation
Description
Evaluation of procedure and/or product related adverse events
Time Frame
through 12 months post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Steinberg, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trinity J Bivalacqua, M.D., Ph.D.
Organizational Affiliation
The Johns Hopkins Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

We'll reach out to this number within 24 hrs