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

Neurogenic Bladder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00512148
• Other study ID #: TNG-CL004
• Secondary ID: NOTE: TENGION NO
• Status: Terminated
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: April 2011

Study information

• Verified date: August 2018
• Source: Tengion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

Device:
• Autologous neobladder construct
augmentation cystoplasty with autologous neo-bladder construct

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 12 months
Primary	Overall Safety Profile - Number of Participants Experiencing an Adverse Event	Clinical evaluation of adverse events experienced by patients enrolled in the trial.	through month 12
Secondary	Urodynamic Measurements and Long Term Safety	Safety results are summarized in the Adverse Events section of this listing.	month 12 through month 60