Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
- Conditions
- Bladder Cancer
- Interventions
- Device: Neo-Urinary Conduit
- Registration Number
- NCT01087697
- Lead Sponsor
- Tengion
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implanted with NUC Neo-Urinary Conduit Patients who have been implanted with the Neo-Urinary Conduit
- Primary Outcome Measures
Name Time Method Structural integrity and conduit patency 12 months post implantation CT scan will be used to demonstrate that urine is able to flow safety through the NUC
- Secondary Outcome Measures
Name Time Method Structural integrity and conduit patency month 12 through month 60 post implantation 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
Procedure and/or product related AEs month 12 through month 60 post implant procedure and/or product related AEs will be evaluated through month 60 post implantation
Overall safety from enrollment through month 60 post implant overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters
Procedure and/or product related adverse events post implantation through 12 months post implantation Evaluation of procedure and/or product related adverse events
Trial Locations
- Locations (6)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
The Johns Hopkins Medical Institutions
🇺🇸Baltimore, Maryland, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States