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Sponsored by: |
Tengion |
Information provided by: | Tengion |
ClinicalTrials.gov Identifier: | NCT00419120 |
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 |
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 |
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
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Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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