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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

Conditions
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Neurogenic Bladder

Intervention / Treatment
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* Device: Autologous neobladder construct


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* augmentation cystoplasty with autologous neo-bladder construct<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic Measurements and Long Term Safety | Safety results are summarized in the Adverse Events section of this listing. | month 12 through month 60 |