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Augmentation Cystoplasty Using an Autologous Neo-Bladder

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ClinicalTrials.gov Identifier: NCT00419120
Recruitment Status : Terminated (36 months follow up without change to profile. No further studies planned.)
First Posted : January 8, 2007
Results First Posted : June 7, 2010
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Tengion

Study Description
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Brief Summary:
Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Biological: Autologous neo bladder construct Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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 Spina Bifida
Study Start Date : December 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Neo-bladder construction
Surgical implantation of autologous neo-bladder construct
 Biological: Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct


Outcome Measures
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Primary Outcome Measures :
  1. Number of Responders as Assessed by Compliance [ Time Frame: 12 months ]
    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 :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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): NCT00419120


Locations
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United States, Massachusetts
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Tengion
Investigators
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Study Director: Sunita Sheth, MD Tengion, Inc.
More Information
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Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT00419120    
Other Study ID Numbers: TNG-CL003
First Posted: January 8, 2007    Key Record Dates
Results First Posted: June 7, 2010
Last Update Posted: November 30, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases