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| ID | Type | Description | Link |
|---|---|---|---|
| NOTE: TENGION NO LONGER EXISTS | Other Identifier | NOTE: TENGION NO LONGER EXISTS FOLLOWING CHAPTER 7 BANKRUPTCY IN 2014. NO FURTHER INFORMATION IS AVAILABLE. |
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24 months follow up completed without substantial change to the profile.
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Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Receipt of autologous neo-bladder construct consisting of a device regenerated in the laboratory from the patient's own muscle and urothelial cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous neobladder construct | Device | augmentation cystoplasty with autologous neo-bladder construct |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum Detrusor Pressure From Baseline to 12 Months | Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure. | baseline and 12 months |
| Overall Safety Profile - Number of Participants Experiencing an Adverse Event | Clinical evaluation of adverse events experienced by patients enrolled in the trial. | through month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic Measurements and Long Term Safety | Safety results are summarized in the Adverse Events section of this listing. | month 12 through month 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunita Sheth, MD | Tengion, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
This was an open label, single arm study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primay Study Period |
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| ||||||||||||||||||
| Long Term Follow Up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maximum Detrusor Pressure From Baseline to 12 Months | Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure. | All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis. | Posted | Mean | 95% Confidence Interval | centimeters of water (cm H2O) | baseline and 12 months |
|
periodically within the first 12 months as well as during long term follow up out to 5 years.
Adverse events are reported for 7 subjects who were enrolled in the study. One patient withdrew prior to bladder biopsy and is included in the safety population but not in the all implanted population used for efficacy analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | Patients who underwent screening procedures and met inclusion/exclusion criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tengion declared bankruptcy and there is no results contact | Tengion declared bankruptcy in 2014 | There is no Tengion phone |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
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Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Overall Safety Profile - Number of Participants Experiencing an Adverse Event | Clinical evaluation of adverse events experienced by patients enrolled in the trial. | This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made. | Posted | Number | participants | through month 12 |
|
|
|
| Secondary | Urodynamic Measurements and Long Term Safety | Safety results are summarized in the Adverse Events section of this listing. | Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed. | Posted | month 12 through month 60 |
|
|
| 4 |
| 7 |
| 6 |
| 7 |
| Post procedural urine leak | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Methicillin resistant Staphylococcus aureus test positive | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Catheter site rash | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection fungal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bladder neck obstruction | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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.
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |