Augmentation Cystoplasty Using an Autologous Neo-Bladder - Full Text View

Purpose

Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Condition	Intervention	Phase
Neurogenic Bladder	Other: Autologous neo bladder construct	Phase II

MedlinePlus related topics:

Spina Bifida

ChemIDplus related topics:

Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida

Further study details as provided by Tengion:

Primary Outcome Measures:

Urodynamic assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

urodynamics and safety [ Time Frame: periodically within first 12 months as well as during long term follow up out to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	December 2006
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Receipt of autologous neo-bladder construct	Other: Autologous neo bladder construct augmentation cystoplasty with autologous neo-bladder construct

Eligibility

Ages Eligible for Study:	3 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria:

prior augment procedures
recent urologic surgery
requires concomitant urologic intervention

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419120

Locations


United States, Massachusetts
	Boston Childrens Hospital
	Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Tengion

More Information

Responsible Party:	Tengion, Inc ( Elyse Seltzer, MD )
Study ID Numbers:	TNG-CL003
First Received:	January 4, 2007
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00419120
Health Authority:	United States: Food and Drug Administration