A Phase 2 interventional study of Autologous neo bladder construct in Neurogenic Bladder, sponsored by Tengion. Terminated at 1 site in United States. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by Tengion · Phase 2, Interventional, and Treatment
Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.
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.
185 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 10 is below the median of 36 across 124 interventional studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →Tengion is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Surgical implantation of autologous neo-bladder construct
Biological: Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct
Number of Responders as Assessed by Compliance
Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders
Time frame: 12 months
Overall Safety Profile - Number of Participants Experiencing an Adverse Event
clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.
Time frame: periodically within first 12 months as well as during long term follow up out to 5 years
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).
| Milestone | Implanted Patients |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
| Milestone | Implanted Patients |
|---|---|
| Started | 10 |
| Completed | 0 |
| Not completed | 10 |
| Withdrew: Study ongoing | 10 |
Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders
| participants | Implanted Patients |
|---|---|
| Number of Responders as Assessed by Compliance | 6 |
clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.
| participants | Implanted Patients |
|---|---|
| Overall Safety Profile - Number of Participants Experiencing an Adverse Event | 10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Population | — | 6/11 (54.5%) | 11/11 (100%) |
| Event | Safety Population |
|---|---|
| Ventriculoperitoneal Shunt MalfunctionInjury, poisoning and procedural complications | 3/11 |
| DehydrationMetabolism and nutrition disorders | 2/11 |
| PyrexiaGeneral disorders | 2/11 |
| Urinary Tract InfectionInfections and infestations | 2/11 |
| DiarrhoeaGastrointestinal disorders | 1/11 |
| FaecalomaGastrointestinal disorders | 1/11 |
| PyelonephritisInfections and infestations | 1/11 |
| Complication of Device InsertionInjury, poisoning and procedural complications | 1/11 |
| Post Procedural Urine LeakInjury, poisoning and procedural complications | 1/11 |
| Event | Safety Population |
|---|---|
| Urinary Tract InfectionInfections and infestations | 10/11 |
| NauseaGastrointestinal disorders | 5/11 |
| VomitingGastrointestinal disorders | 5/11 |
| PyrexiaGeneral disorders | 5/11 |
| NasopharyngitisInfections and infestations | 3/11 |
| Clostridial InfectionInfections and infestations | 2/11 |
| HeadacheNervous system disorders | 2/11 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/11 |
| PruritusSkin and subcutaneous tissue disorders | 2/11 |
| RashSkin and subcutaneous tissue disorders | 2/11 |
| Age, Categorical(Participants) | Implanted Patients |
|---|---|
| <=18 years | 10 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Implanted Patients |
|---|---|
| Mean | 8.2 ± 4.29 |
| Sex: Female, Male(Participants) | Implanted Patients |
|---|---|
| Female | 6 |
| Male | 4 |
| Region of Enrollment(participants) | Implanted Patients |
|---|---|
| United States | 10 |
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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