Neurogenic BladderPhase 2NCT00512148

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

A Phase 2 study testing Autologous neobladder construct in people with Neurogenic Bladder, run by Tengion at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurogenic Bladder
What is being tested?: Autologous neobladder construct
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Apr 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

subjects with neurogenic bladders secondary to spinal cord injury

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

Conditions: Neurogenic Bladder
Being tested: Autologous neobladder construct
Medical subject headings: Urinary Bladder, Neurogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous neobladder constructDevice
augmentation cystoplasty with autologous neo-bladder construct

Study groups in NCT00512148
Study group	Role	What they receive
1	Experimental	Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells Receives: Device: Autologous neobladder construct

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: through month 12

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Apr 2011

First posted7 Aug 2007 (estimated)
Study startJul 2007
Primary completionJan 2010
Study completionApr 2011

Why it stopped: 24 months follow up completed without substantial change to the profile.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neurogenic BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00512148
Sponsor's protocol ID: TNG-CL004
Other IDs: NOTE: TENGION NO LONGER EXISTS
Status last verified: Aug 2018
First submitted: 3 Aug 2007
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder

All Neurogenic Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00512148
Acronym / sponsor ID: TNG-CL004
Conditions: Neurogenic Bladder
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: 24 months follow up completed without substantial change to the profile.
Enrolment: 7 participants (actual)
Lead sponsor: TengionIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jan 2010 (actual)
Study completion: Apr 2011 (actual)
First posted: 7 Aug 2007 (estimated)
Results: Posted 3 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
1	Experimental	Device: Autologous neobladder constructReceipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

subjects with neurogenic bladders secondary to spinal cord injury

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous neobladder constructaugmentation cystoplasty with autologous neo-bladder construct	Device	1

Primary outcome

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.

1 secondary outcome

Urodynamic Measurements and Long Term Safety
Time frame: month 12 through month 60

Results and safety

Results posted to the registry on 3 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enterocystoplasty With the Neo-bladder Augment	7	6

Primary outcome: Change in Maximum Detrusor Pressure From Baseline to 12 Months

Time frame: baseline and 12 months. Mean (95% Confidence Interval). Unit: centimeters of water (cm H2O)

Measure	All Implanted n = 5
Value	-17.0 (-61.4 to 27.4)

Population analysed: All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.

Primary outcome: Overall Safety Profile - Number of Participants Experiencing an Adverse Event

Time frame: through month 12. Number. Unit: participants

Measure	Enterocystoplasty With the Neo-bladder Augment n = 7
Value	7

Population analysed: This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: periodically within the first 12 months as well as during long term follow up out to 5 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	4 of 7 (57.1%)	6 of 7 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neurogenic Bladder

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sunita Sheth, MD study director

Tengion, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous neobladder construct in people with Neurogenic Bladder, run by Tengion at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maximum Detrusor Pressure From Baseline to 12 Months (time frame: baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00512148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.