Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00512148
Recruitment Status : Terminated (24 months follow up completed without substantial change to the profile.)
First Posted : August 7, 2007
Results First Posted : February 3, 2011
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Tengion

Brief 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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Device: Autologous neobladder construct Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Masking 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.
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
Study Start Date : July 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Tengion
Investigators
Layout table for investigator information
Study Director: Sunita Sheth, MD Tengion, Inc
Layout table for additonal information
Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT00512148    
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. )
First Posted: August 7, 2007    Key Record Dates
Results First Posted: February 3, 2011
Last Update Posted: August 17, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for 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