Augmentation Cystoplasty Using an Autologous Neo-Bladder

Neurogenic Bladder Clinical Trial

Official title:

An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00419120
• Other study ID #: TNG-CL003
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: November 2, 2015
• Start date: December 2006
• Est. completion date: April 2011

Study information

• Verified date: November 2015
• Source: Tengion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

Inclusion Criteria:

• subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria:

• prior augment procedures

• recent urologic surgery

• requires concomitant urologic intervention

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Biological:
• Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	periodically within first 12 months as well as during long term follow up out to 5 years	Yes