Trial Outcomes & Findings for Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury (NCT NCT00512148)

Last Updated: 2018-08-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

baseline and 12 months

Results posted on

2018-08-17

Participant Flow

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.

This was an open label, single arm study.

Participant milestones

Participant milestones
Measure	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.
Primay Study Period STARTED	7
Primay Study Period COMPLETED	6
Primay Study Period NOT COMPLETED	1
Long Term Follow Up Period STARTED	6
Long Term Follow Up Period COMPLETED	0
Long Term Follow Up Period NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Primay Study Period Withdrawal by Subject	1

Baseline Characteristics

Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enterocystoplasty With the Neo-bladder Augment n=7 Participants 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.7 years STANDARD_DEVIATION 11.41 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 months

Population: All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.

Outcome measures

Outcome measures
Measure	All Implanted n=5 Participants The number of subjects implanted with the neobladder augment
Change in Maximum Detrusor Pressure From Baseline to 12 Months	-17.0 centimeters of water (cm H2O) Interval -61.4 to 27.4

PRIMARY outcome

Timeframe: through month 12

Population: 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.

Clinical evaluation of adverse events experienced by patients enrolled in the trial.

Outcome measures

Outcome measures
Measure	All Implanted n=7 Participants The number of subjects implanted with the neobladder augment
Overall Safety Profile - Number of Participants Experiencing an Adverse Event	7 participants

SECONDARY outcome

Timeframe: month 12 through month 60

Population: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.

Safety results are summarized in the Adverse Events section of this listing.

Outcome measures

Outcome data not reported

Adverse Events

Safety Population

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Population n=7 participants at risk Patients who underwent screening procedures and met inclusion/exclusion criteria.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • 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.
Injury, poisoning and procedural complications Post procedural urine leak	42.9% 3/7 • Number of events 3 • 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.
Investigations Methicillin resistant Staphylococcus aureus test positive	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Bladder perforation	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Renal failure acute	14.3% 1/7 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Safety Population n=7 participants at risk Patients who underwent screening procedures and met inclusion/exclusion criteria.
Gastrointestinal disorders Nausea	71.4% 5/7 • Number of events 11 • 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.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 3 • 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.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 3 • 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.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhoea haemorrhagic	14.3% 1/7 • Number of events 1 • 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.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	14.3% 1/7 • Number of events 2 • 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.
General disorders Pyrexia	42.9% 3/7 • Number of events 4 • 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.
General disorders Edema peripheral	28.6% 2/7 • Number of events 2 • 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.
General disorders Catheter site rash	14.3% 1/7 • Number of events 1 • 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.
Immune system disorders Hypersensitivity	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Urinary tract infection	85.7% 6/7 • Number of events 18 • 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.
Infections and infestations Bacteriuria	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Bronchitis	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Candidiasis	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Cystitis	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Fungal infection	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Perianal abscess	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Skin infection	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Urinary tract infection fungal	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Vulvovaginal mycotic infection	14.3% 1/7 • Number of events 1 • 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.
Injury, poisoning and procedural complications Procedural pain	42.9% 3/7 • Number of events 5 • 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.
Injury, poisoning and procedural complications Abdominal wound dehiscence	14.3% 1/7 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incision site pain	14.3% 1/7 • Number of events 2 • 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.
Injury, poisoning and procedural complications Operative haemorrhage	14.3% 1/7 • Number of events 1 • 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.
Injury, poisoning and procedural complications Post procedural discharge	14.3% 1/7 • Number of events 1 • 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.
Injury, poisoning and procedural complications Wound	14.3% 1/7 • Number of events 1 • 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.
Metabolism and nutrition disorders Decreased appetite	14.3% 1/7 • Number of events 1 • 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.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • Number of events 1 • 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.
Metabolism and nutrition disorders Electrolyte imbalance	14.3% 1/7 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Trigger finger	14.3% 1/7 • Number of events 1 • 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.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 2 • 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.
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • 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.
Nervous system disorders Lethargy	14.3% 1/7 • Number of events 1 • 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.
Psychiatric disorders Anxiety	28.6% 2/7 • Number of events 4 • 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.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 1 • 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.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 4 • 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.
Psychiatric disorders Mental status changes	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Bladder neck obstruction	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Stress urinary incontinence	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Urinary retention	14.3% 1/7 • Number of events 1 • 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.
Reproductive system and breast disorders Penile pain	14.3% 1/7 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Blister	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Ingrowing nail	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Ingrown hair	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • 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.

Additional Information

Tengion declared bankruptcy and there is no results contact

Tengion declared bankruptcy in 2014

Phone: There is no Tengion phone

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER