Clinical trial NCT01087697: Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
Official title: A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: bladder cancer
radical cystectomy
incontinent urinary diversion
Lead sponsor: Tengion
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Structural integrity and conduit patency
timeFrame: 12 months post implantation
Secondary outcomes:
measure: Structural integrity and conduit patency
timeFrame: month 12 through month 60 post implantation
measure: Procedure and/or product related AEs
timeFrame: month 12 through month 60 post implant
measure: Overall safety
timeFrame: from enrollment through month 60 post implant
measure: Procedure and/or product related adverse events post implantation
timeFrame: through 12 months post implantation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: The Johns Hopkins Medical Institutions
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Chicago
name: Gary Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Johns Hopkins Medical Institute
name: Trinity J Bivalacqua, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: