Study Stopped
36 months follow up without change to profile. No further studies planned.
Augmentation Cystoplasty Using an Autologous Neo-Bladder
An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedResults Posted
Study results publicly available
June 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedNovember 30, 2015
November 1, 2015
1.8 years
January 4, 2007
December 8, 2009
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Responders as Assessed by Compliance
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
12 months
Secondary Outcomes (1)
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
periodically within first 12 months as well as during long term follow up out to 5 years
Study Arms (1)
Neo-bladder construction
EXPERIMENTALSurgical implantation of autologous neo-bladder construct
Interventions
augmentation cystoplasty with autologous neo-bladder construct
Eligibility Criteria
You may qualify if:
- subjects with neurogenic bladders secondary to myleodysplasia
You may not qualify if:
- prior augment procedures
- recent urologic surgery
- requires concomitant urologic intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tengionlead
Study Sites (1)
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sunita Sheth, MD - Chief Medical Officer
- Organization
- Tengion, Inc.
Study Officials
- STUDY DIRECTOR
Sunita Sheth, MD
Tengion, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2007
First Posted
January 8, 2007
Study Start
December 1, 2006
Primary Completion
October 1, 2008
Study Completion
April 1, 2011
Last Updated
November 30, 2015
Results First Posted
June 7, 2010
Record last verified: 2015-11