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

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury

NCT04879862

Spinal Cord Injuries

RECRUITING NA

Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

NCT06515223

Spinal Cord Injuries Neuromodulation Neurogenic Bladder +2 more

RECRUITING NA

Colonizing Neurogenic Bladders With Benign Flora

NCT00371631

Spinal Cord Injury Urinary Tract Infection

COMPLETED PHASE1

Time Needed to Perform Intermittent Catheterization in Adults With Spinal Cord Injuries

NCT05003999

Spinal Cord Injuries Neurogenic Lower Urinary Tract Dysfunction

COMPLETED NA

Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

NCT04193709

Urinary Bladder, Neurogenic Blood Pressure Autonomic Dysreflexia +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurogenic Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Autologous neobladder construct

Intervention Type DEVICE

augmentation cystoplasty with autologous neo-bladder construct

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous neobladder construct

augmentation cystoplasty with autologous neo-bladder construct

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No