Augmentation Cystoplasty Using an Autologous Neo-Bladder

Phase 2

Terminated

• Conditions: Neurogenic Bladder
• Interventions: Biological: Autologous neo bladder construct

• Registration Number: NCT00419120
• Lead Sponsor: Tengion

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Primary Completion: 2008-10
• Results First Submitted: 2009-12-08
• Results First Submitted QC: 2010-05-12
• Results First Posted: 2010-06-07
• Study Completion: 2011-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria

• prior augment procedures
• recent urologic surgery
• requires concomitant urologic intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neo-bladder construction	Autologous neo bladder construct	Surgical implantation of autologous neo-bladder construct

Primary Outcome Measures

Name	Time	Method
Number of Responders as Assessed by Compliance	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Boston Childrens Hospital; 🇺🇸 Boston, Massachusetts, United States