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Augmentation Cystoplasty Using an Autologous Neo-Bladder

NCT00419120 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-11-30

Study results available
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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.

Conditions

  • Neurogenic Bladder

Interventions

BIOLOGICAL

Autologous neo bladder construct

augmentation cystoplasty with autologous neo-bladder construct

Sponsors & Collaborators

  • Tengion

    lead INDUSTRY

Principal Investigators

  • Sunita Sheth, MD · Tengion, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-10-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00419120 on ClinicalTrials.gov