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Augmentation Cystoplasty Using an Autologous Neo-Bladder

This study has been terminated.
(36 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:
NCT00419120
First received: January 4, 2007
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
  Purpose

Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.


Condition Intervention Phase
Neurogenic Bladder
 Other: Autologous neo bladder 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 Spina Bifida

Resource links provided by NLM:

MedlinePlus related topics: Spina Bifida
U.S. FDA Resources

Further study details as provided by Tengion:

Primary Outcome Measures:
  • Number of Responders as Assessed by Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders


Secondary Outcome Measures:
  • Overall Safety Profile - Number of Participants Experiencing an Adverse Event [ Time Frame: periodically within first 12 months as well as during long term follow up out to 5 years ] [ 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 the Adverse Event section for detailed information.


Enrollment: 10
Study Start Date: December 2006
Study Completion Date: April 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receipt of autologous neo-bladder construct
 Other: Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria:

  • prior augment procedures
  • recent urologic surgery
  • requires concomitant urologic intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419120

Locations
United States, Massachusetts
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Tengion
Investigators
Study Director: Sunita Sheth, MD Tengion, Inc.
  More Information

No publications provided

Responsible Party: Sunita Sheth, MD, Tengion, Inc
ClinicalTrials.gov Identifier: NCT00419120     History of Changes
Other Study ID Numbers: TNG-CL003
Study First Received: January 4, 2007
Results First Received: December 8, 2009
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
 Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013