Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

Study Overview
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Brief Summary
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The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

Detailed Description
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The NUC under investigation is a regenerative medicine product comprised of the patient's own smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate culture conditions to reproducibly generate the necessary quantities of SMC in vitro from autologous adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing Practices (GMP) qualified clinical production facility. In this process, smooth muscle cells (SMC) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. At the end of this process, the SMCs are seeded onto the surface of a biodegradable PGA/PLGA mesh scaffold to form the NUC. The NUC is shipped to the investigative site for surgical implantation. Over time, the NUC should facilitate the regeneration of urinary tract tissue.

Official Title
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A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Neo-Urinary Conduit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 18 - 80 years of age Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0 Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy Exclusion Criteria: History of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer) Evidence of cancer metastasis History of any pelvic radiation or non-pelvic radiation within past 5 years Debilitating cardiac or pulmonary disease Expected need for chemotherapy within 3 months post cystectomy Life expectancy less than 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implanted with NUC<br>Patients who have been implanted with the Neo-Urinary Conduit | Device: Neo-Urinary Conduit<br>* Implantation with the autologous Neo-Urinary Conduit<br>* Other names: NUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural integrity and conduit patency | CT scan will be used to demonstrate that urine is able to flow safety through the NUC | 12 months post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural integrity and conduit patency | CT scan and renal ultrasound will be used to demonstrate that urine is able to flow safely through the NUC through 60 months post implantation | month 12 through month 60 post implantation | 
| Procedure and/or product related AEs | procedure and/or product related AEs will be evaluated through month 60 post implantation | month 12 through month 60 post implant | 
| Overall safety | overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters | from enrollment through month 60 post implant | 
| Procedure and/or product related adverse events post implantation | Evaluation of procedure and/or product related adverse events | through 12 months post implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, radical cystectomy, incontinent urinary diversion