Bladder Cancer
Conditions
Keywords
bladder cancer, radical cystectomy, incontinent urinary diversion
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.
Interventions
DEVICENeo-Urinary Conduit
Implantation with the autologous Neo-Urinary Conduit
Sponsors
Tengion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed