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Augmentation 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
Tengion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bladder

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 4, 2007
Last Updated
November 2, 2015
Sponsor
Tengion
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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

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Augmentation Cystoplasty Using an Autologous Neo-Bladder

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