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

This study has been terminated.
(24 months follow up completed without substantial change to the profile.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512148
First Posted: August 7, 2007
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tengion
  Purpose
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.

Condition Intervention Phase
Neurogenic Bladder Device: Autologous neobladder construct Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tengion:

Primary Outcome Measures:
  • 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, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to adverse event section for detailed information.


Secondary Outcome Measures:
  • Urodynamic Measurements and Long Term Safety [ Time Frame: month 12 through month 60 ]

Enrollment: 7
Study Start Date: July 2007
Study Completion Date: April 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receipt of autologous neo-bladder construct
Device: Autologous neobladder construct
augmentation cystoplasty with autologous neo-bladder construct

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512148


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Tengion
Investigators
Study Director: Sunita Sheth, MD Tengion, Inc
  More Information

Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT00512148     History of Changes
Other Study ID Numbers: TNG-CL004
First Submitted: August 3, 2007
First Posted: August 7, 2007
Results First Submitted: December 20, 2010
Results First Posted: February 3, 2011
Last Update Posted: June 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms