Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT00512148|
Recruitment Status : Terminated (24 months follow up completed without substantial change to the profile.)
First Posted : August 7, 2007
Results First Posted : February 3, 2011
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neurogenic Bladder||Device: Autologous neobladder construct||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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.|
|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 Start Date :||July 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||April 2011|
Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells
Device: Autologous neobladder construct
augmentation cystoplasty with autologous neo-bladder construct
- Change in Maximum Detrusor Pressure From Baseline to 12 Months [ Time Frame: baseline and 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 [ Time Frame: through month 12 ]Clinical evaluation of adverse events experienced by patients enrolled in the trial.
- Urodynamic Measurements and Long Term Safety [ Time Frame: month 12 through month 60 ]Safety results are summarized in the Adverse Events section of this listing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512148
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Sunita Sheth, MD||Tengion, Inc|