Back to resultsStudy of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Primary Purpose
Neurogenic Bladder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous neobladder construct
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Bladder
Eligibility Criteria
Inclusion Criteria:
- subjects with neurogenic bladders secondary to spinal cord injury
Exclusion Criteria:
- prior augmentation procedures or urinary diversion
- recent urologic or intraperitoneal surgery or device implantation
- recent history of spinal cord injury of less than a year
- recent neurologic surgery
- requirement for concomitant urological surgical procedures
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells
Outcomes
Primary Outcome Measures
Change in Maximum Detrusor Pressure From Baseline to 12 Months
Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Clinical evaluation of adverse events experienced by patients enrolled in the trial.
Secondary Outcome Measures
Urodynamic Measurements and Long Term Safety
Safety results are summarized in the Adverse Events section of this listing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00512148
Brief Title
Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Official Title
An Open Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
24 months follow up completed without substantial change to the profile.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2011 (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
Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Masking
None (Open Label)
Masking Description
Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells
Intervention Type
Device
Intervention Name(s)
Autologous neobladder construct
Intervention Description
augmentation cystoplasty with autologous neo-bladder construct
Primary Outcome Measure Information:
Title
Change in Maximum Detrusor Pressure From Baseline to 12 Months
Description
Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.
Time Frame
baseline and 12 months
Title
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Description
Clinical evaluation of adverse events experienced by patients enrolled in the trial.
Time Frame
through month 12
Secondary Outcome Measure Information:
Title
Urodynamic Measurements and Long Term Safety
Description
Safety results are summarized in the Adverse Events section of this listing.
Time Frame
month 12 through month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects with neurogenic bladders secondary to spinal cord injury
Exclusion Criteria:
prior augmentation procedures or urinary diversion
recent urologic or intraperitoneal surgery or device implantation
recent history of spinal cord injury of less than a year
recent neurologic surgery
requirement for concomitant urological surgical procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Sheth, MD
Organizational Affiliation
Tengion, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
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