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

August 15, 2018 updated by: Tengion

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 12 months
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.
through month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 12 through month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tengion

Investigators

  • Study Director: Sunita Sheth, MD, Tengion, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNG-CL004
  • NOTE: TENGION NO LONGER EXISTS (Other Identifier: NOTE: TENGION NO LONGER EXISTS FOLLOWING CHAPTER 7 BANKRUPTCY IN 2014. NO FURTHER INFORMATION IS AVAILABLE.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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