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Augmentation Cystoplasty Using an Autologous Neo-Bladder

NCT ID: NCT00419120

Last Updated: 2015-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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

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Neurogenic Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neo-bladder construction

Surgical implantation of autologous neo-bladder construct

Group Type EXPERIMENTAL

Autologous neo bladder construct

Intervention Type BIOLOGICAL

augmentation cystoplasty with autologous neo-bladder construct

Interventions

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Autologous neo bladder construct

augmentation cystoplasty with autologous neo-bladder construct

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria

* prior augment procedures
* recent urologic surgery
* requires concomitant urologic intervention
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tengion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunita Sheth, MD

Role: STUDY_DIRECTOR

Tengion, Inc.

Locations

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Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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TNG-CL003

Identifier Type: -

Identifier Source: org_study_id