Augmentation Cystoplasty Using an Autologous Neo-Bladder

Tengion

Status and phase: Terminated; Phase 2

Conditions: Neurogenic Bladder

Treatments: Biological: Autologous neo bladder construct

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419120

TNG-CL003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects with neurogenic bladders secondary to myleodysplasia

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Neo-bladder construction

Experimental group

Description:

Surgical implantation of autologous neo-bladder construct

Treatment:

Biological: Autologous neo bladder construct