Augmentation Cystoplasty Using an Autologous Neo-Bladder

This study has been terminated.

(36 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:

NCT00419120

First received: January 4, 2007

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Results First Received: December 8, 2009

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 neo bladder 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
11 patients were recruited between Dec 2006 and July 2007. Patients were recruited from 4 academic centers across the US. One patient withdrew from the study prior to implantation of the Neo-bladder construct and is included in the safety analysis, but not in the efficacy analysis (all implanted population).

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
Implanted Patients	Patients implanted with Tengion Neo-Bladder Augment

Participant Flow for 2 periods

Period 1: Primary Study Period

	Implanted Patients
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Period 2: Long Term Follow up Period

	Implanted Patients
STARTED	10 ^[1]
COMPLETED	0
NOT COMPLETED	10
study ongoing	10

[1]	10 patients are being followed in long term follow up.

Baseline Characteristics

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Reporting Groups

	Description
Implanted Patients	Patients implanted with Tengion Neo-Bladder Augment

Baseline Measures

	Implanted Patients
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	10
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	8.2 ± 4.29
Gender [units: participants]
Female	6
Male	4
Region of Enrollment [units: participants]
United States	10

Outcome Measures

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1. Primary:

Number of Responders as Assessed by Compliance [ Time Frame: 12 months ]

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2. Secondary:

Overall Safety Profile - Number of Participants Experiencing an Adverse Event [ Time Frame: periodically within first 12 months as well as during long term follow up out to 5 years ]

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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 entirely 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, Inc.
phone: 267-960-4805
e-mail: sunita.sheth@tengion.com

No publications provided

Responsible Party:	Sunita Sheth, MD, Tengion, Inc
ClinicalTrials.gov Identifier:	NCT00419120 History of Changes
Other Study ID Numbers:	TNG-CL003
Study First Received:	January 4, 2007
Results First Received:	December 8, 2009
Last Updated:	August 9, 2011
Health Authority:	United States: Food and Drug Administration

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