Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

Tengion

Status and phase: Terminated; Phase 2

Conditions: Neurogenic Bladder

Treatments: Device: Autologous neobladder construct

Study type: Interventional

Funder types: Industry

Identifiers

NCT00512148

NOTE: TENGION NO LONGER EXISTS (Other Identifier)

TNG-CL004

Details and patient eligibility

About

Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects with neurogenic bladders secondary to spinal cord injury

Exclusion criteria

• prior augmentation procedures or urinary diversion
• recent urologic or intraperitoneal surgery or device implantation
• recent history of spinal cord injury of less than a year
• recent neurologic surgery
• requirement for concomitant urological surgical procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

1

Experimental group

Description:

Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells

Treatment:

Device: Autologous neobladder construct