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

This study has been terminated.
(24 months of longterm follow up have been completed without substantial change to the profile. No further studies are currently planned)
Sponsor:
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00512148
First received: August 3, 2007
Last updated: August 9, 2011
Last verified: August 2011
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neurogenic Bladder
Intervention: Other: Autologous neobladder construct

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open label, single arm study.

Reporting Groups
  Description
Enterocystoplasty With the Neo-bladder Augment 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.

Participant Flow for 2 periods

Period 1:   Primay Study Period
    Enterocystoplasty With the Neo-bladder Augment  
STARTED     7  
COMPLETED     6  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 2:   Long Term Follow Up Period
    Enterocystoplasty With the Neo-bladder Augment  
STARTED     6  
COMPLETED     0 [1]
NOT COMPLETED     6  
[1] 6 patients are being followed in long term follow up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enterocystoplasty With the Neo-bladder Augment 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.

Baseline Measures
    Enterocystoplasty With the Neo-bladder Augment  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.7  ± 11.41  
Gender  
[units: participants]
 
Female     2  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   Change in Maximum Detrusor Pressure From Baseline to 12 Months   [ Time Frame: baseline and 12 months ]

2.  Primary:   Overall Safety Profile - Number of Participants Experiencing an Adverse Event   [ Time Frame: through month 12 ]

3.  Secondary:   Urodynamic Measurements and Long Term Safety   [ Time Frame: month 12 through month 60 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Sunita Sheth, MD - Chief Medical Officer
Organization: Tengion
phone: 610 292 8364
e-mail: info@tengion.com


No publications provided


Responsible Party: Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
ClinicalTrials.gov Identifier: NCT00512148     History of Changes
Other Study ID Numbers: TNG-CL004
Study First Received: August 3, 2007
Results First Received: December 20, 2010
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration