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

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ClinicalTrials.gov Identifier: NCT00512148
Recruitment Status : Terminated (24 months follow up completed without substantial change to the profile.)
First Posted : August 7, 2007
Results First Posted : February 3, 2011
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Tengion

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neurogenic Bladder
Intervention Device: Autologous neobladder construct
Enrollment 7
Recruitment Details 7 patients were recruited between September 2007 and October 2008. Patients were recruited from 4 academic centers across the US. 1 patient withdrew consent prior to bladder biopsy and is included in the safety analysis but not in the efficacy analysis. Due to recruitment challenges, only 6 patients were implanted.
Pre-assignment Details This was an open label, single arm study.
Arm/Group Title Enterocystoplasty With the Neo-bladder Augment
Hide Arm/Group Description Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
Period Title: Primay Study Period
Started 7
Completed 6
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Long Term Follow Up Period
Started 6
Completed 0 [1]
Not Completed 6
[1]
6 patients are being followed in long term follow up
Arm/Group Title Enterocystoplasty With the Neo-bladder Augment
Hide Arm/Group Description Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
1
  14.3%
Between 18 and 65 years
6
  85.7%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
28.7  (11.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Change in Maximum Detrusor Pressure From Baseline to 12 Months
Hide Description 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.
Time Frame baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.
Arm/Group Title All Implanted
Hide Arm/Group Description:
The number of subjects implanted with the neobladder augment
Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: centimeters of water (cm H2O)
-17.0
(-61.4 to 27.4)
2.Primary Outcome
Title Overall Safety Profile - Number of Participants Experiencing an Adverse Event
Hide Description Clinical evaluation of adverse events experienced by patients enrolled in the trial.
Time Frame through month 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made.
Arm/Group Title Enterocystoplasty With the Neo-bladder Augment
Hide Arm/Group Description:
Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
7
3.Secondary Outcome
Title Urodynamic Measurements and Long Term Safety
Hide Description Safety results are summarized in the Adverse Events section of this listing.
Time Frame month 12 through month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.
Arm/Group Title Patients Treated
Hide Arm/Group Description:
Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame periodically within the first 12 months as well as during long term follow up out to 5 years.
Adverse Event Reporting Description Adverse events are reported for 7 subjects who were enrolled in the study. One patient withdrew prior to bladder biopsy and is included in the safety population but not in the all implanted population used for efficacy analysis.
 
Arm/Group Title Safety Population
Hide Arm/Group Description Patients who underwent screening procedures and met inclusion/exclusion criteria.
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Safety Population
Affected / at Risk (%) # Events
Total   4/7 (57.14%)    
Gastrointestinal disorders   
Small intestinal obstruction  1  1/7 (14.29%)  1
Injury, poisoning and procedural complications   
Post procedural urine leak  1  3/7 (42.86%)  3
Investigations   
Methicillin resistant Staphylococcus aureus test positive  1  1/7 (14.29%)  1
Renal and urinary disorders   
Bladder perforation  1  1/7 (14.29%)  1
Renal failure acute  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Safety Population
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Gastrointestinal disorders   
Nausea  1  5/7 (71.43%)  11
Vomiting  1  3/7 (42.86%)  3
Abdominal pain  1  1/7 (14.29%)  3
Diarrhoea  1  1/7 (14.29%)  1
Diarrhoea haemorrhagic  1  1/7 (14.29%)  1
Constipation  1  1/7 (14.29%)  1
Dyspepsia  1  1/7 (14.29%)  2
General disorders   
Pyrexia  1  3/7 (42.86%)  4
Edema peripheral  1  2/7 (28.57%)  2
Catheter site rash  1  1/7 (14.29%)  1
Immune system disorders   
Hypersensitivity  1  1/7 (14.29%)  1
Infections and infestations   
Urinary tract infection  1  6/7 (85.71%)  18
Bacteriuria  1  1/7 (14.29%)  1
Bronchitis  1  1/7 (14.29%)  1
Candidiasis  1  1/7 (14.29%)  1
Cystitis  1  1/7 (14.29%)  1
Fungal infection  1  1/7 (14.29%)  1
Perianal abscess  1  1/7 (14.29%)  1
Skin infection  1  1/7 (14.29%)  1
Upper respiratory tract infection  1  1/7 (14.29%)  1
Urinary tract infection fungal  1  1/7 (14.29%)  1
Vulvovaginal mycotic infection  1  1/7 (14.29%)  1
Injury, poisoning and procedural complications   
Procedural pain  1  3/7 (42.86%)  5
Abdominal wound dehiscence  1  1/7 (14.29%)  1
Incision site pain  1  1/7 (14.29%)  2
Operative haemorrhage  1  1/7 (14.29%)  1
Post procedural discharge  1  1/7 (14.29%)  1
Wound  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/7 (14.29%)  1
Dehydration  1  1/7 (14.29%)  1
Electrolyte imbalance  1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/7 (14.29%)  1
Trigger finger  1  1/7 (14.29%)  1
Nervous system disorders   
Dizziness  1  1/7 (14.29%)  2
Headache  1  1/7 (14.29%)  1
Lethargy  1  1/7 (14.29%)  1
Psychiatric disorders   
Anxiety  1  2/7 (28.57%)  4
Depression  1  1/7 (14.29%)  1
Insomnia  1  1/7 (14.29%)  4
Mental status changes  1  1/7 (14.29%)  1
Renal and urinary disorders   
Bladder neck obstruction  1  1/7 (14.29%)  1
Stress urinary incontinence  1  1/7 (14.29%)  1
Urinary retention  1  1/7 (14.29%)  1
Reproductive system and breast disorders   
Penile pain  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Blister  1  1/7 (14.29%)  1
Decubitus ulcer  1  1/7 (14.29%)  1
Ingrowing nail  1  1/7 (14.29%)  1
Ingrown hair  1  1/7 (14.29%)  1
Rash  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator is free to individually communicate, orally present, or publish in scientific journals or other scholarly media the study information at the conclusion of the study without the prior approval of the sponsor provided that 1) the results of the study in its entirety have been publically disclosed by or with the consent of the sponsor 2)18 months after the conclusion of the study at all sites, whichever is first to occur.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tengion declared bankruptcy and there is no results contact
Organization: Tengion declared bankruptcy in 2014
Phone: There is no Tengion phone
Layout table for additonal information
Responsible Party: Tengion
ClinicalTrials.gov Identifier: NCT00512148    
Other Study ID Numbers: TNG-CL004
NOTE: TENGION NO LONGER EXISTS ( Other Identifier: NOTE: TENGION NO LONGER EXISTS FOLLOWING CHAPTER 7 BANKRUPTCY IN 2014. NO FURTHER INFORMATION IS AVAILABLE. )
First Submitted: August 3, 2007
First Posted: August 7, 2007
Results First Submitted: December 20, 2010
Results First Posted: February 3, 2011
Last Update Posted: August 17, 2018