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

An Open Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

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.

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