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

NCT00512148 | Terminated Phase 2 Results DMC

• 2 other identifiers: TNG-CL004NOTE: TENGION NO LONGER EXISTS
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurogenic Bladder

Outcome Measures

Primary Outcomes (2)

• Change in Maximum Detrusor Pressure From Baseline to 12 Months

  Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.

  baseline and 12 months

• Overall Safety Profile - Number of Participants Experiencing an Adverse Event

  Clinical evaluation of adverse events experienced by patients enrolled in the trial.

  through month 12

Secondary Outcomes (1)

• Urodynamic Measurements and Long Term Safety

  month 12 through month 60

Study Arms (1)

1

EXPERIMENTAL

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

Device: Autologous neobladder construct

Interventions

Autologous neobladder construct DEVICE

augmentation cystoplasty with autologous neo-bladder construct

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with neurogenic bladders secondary to spinal cord injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Tengion: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tengion declared bankruptcy and there is no results contact
• Organization: Tengion declared bankruptcy in 2014

There is no Tengion phone

Study Officials

• Sunita Sheth, MD

  Tengion, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 3, 2007
• First Posted: August 7, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2011
• Last Updated: August 17, 2018
• Results First Posted: February 3, 2011

Record last verified: 2018-08

Locations

US (1)