Back to resultsAugmentation Cystoplasty Using an Autologous Neo-Bladder
Primary Purpose
Neurogenic Bladder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous neo bladder construct
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Bladder
Eligibility Criteria
Inclusion Criteria:
- subjects with neurogenic bladders secondary to myleodysplasia
Exclusion Criteria:
- prior augment procedures
- recent urologic surgery
- requires concomitant urologic intervention
Sites / Locations
- Boston Childrens Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neo-bladder construction
Arm Description
Surgical implantation of autologous neo-bladder construct
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419120
Brief Title
Augmentation Cystoplasty Using an Autologous Neo-Bladder
Official Title
An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
36 months follow up without change to profile. No further studies planned.
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tengion
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neo-bladder construction
Arm Type
Experimental
Arm Description
Surgical implantation of autologous neo-bladder construct
Intervention Type
Biological
Intervention Name(s)
Autologous neo bladder construct
Intervention Description
augmentation cystoplasty with autologous neo-bladder construct
Primary Outcome Measure Information:
Title
Number of Responders as Assessed by Compliance
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Description
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.
Time Frame
periodically within first 12 months as well as during long term follow up out to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects with neurogenic bladders secondary to myleodysplasia
Exclusion Criteria:
prior augment procedures
recent urologic surgery
requires concomitant urologic intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Sheth, MD
Organizational Affiliation
Tengion, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Boston Childrens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Augmentation Cystoplasty Using an Autologous Neo-Bladder
We'll reach out to this number within 24 hrs