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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 of longterm follow up have been completed without substantial change to the profile. No further studies are currently planned)
Sponsor:
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00512148
First received: August 3, 2007
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
  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
 Other: Autologous neobladder construct
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

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
 Other: Autologous neobladder construct
augmentation cystoplasty with autologous neo-bladder construct

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
ClinicalTrials.gov Identifier: NCT00512148     History of Changes
Other Study ID Numbers: TNG-CL004
Study First Received: August 3, 2007
Results First Received: December 20, 2010
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013