Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in Maximum Detrusor Pressure From Baseline to 12 Months [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: through month 12 ] [ Designated as safety issue: Yes ]Clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to adverse event section for detailed information.
- Urodynamic Measurements and Long Term Safety [ Time Frame: month 12 through month 60 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Receipt of autologous neo-bladder construct
Other: Autologous neobladder construct
augmentation cystoplasty with autologous neo-bladder construct
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512148
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Sunita Sheth, MD||Tengion, Inc|