Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

Phase 2

Terminated

• Conditions: Neurogenic Bladder
• Interventions: Device: Autologous neobladder construct

• Registration Number: NCT00512148
• Lead Sponsor: Tengion

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-07
• Primary Completion: 2010-01
• Results First Submitted: 2010-12-20
• Results First Submitted QC: 2011-02-01
• Results First Posted: 2011-02-03
• Study Completion: 2011-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Autologous neobladder construct	Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells

Primary Outcome Measures

Name	Time	Method
Change in Maximum Detrusor Pressure From Baseline to 12 Months	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	through month 12	Clinical evaluation of adverse events experienced by patients enrolled in the trial.

Secondary Outcome Measures

Name	Time	Method
Urodynamic Measurements and Long Term Safety	month 12 through month 60	Safety results are summarized in the Adverse Events section of this listing.

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States