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

History of Changes

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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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 ]

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2. Primary:

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

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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

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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

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