NCT00419120

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tengion · Industry
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Autologous neo bladder construct	augmentation cystoplasty with autologous neo-bladder construct

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-10-01
• Completion: 2011-04-01
• First posted: 2007-01-08
• Last updated: 2015-11-30
• Results posted: 2010-06-07

Locations

1 site across 1 country: United States