Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087697
• Other study ID #: TNG-CL009
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2010
• Last updated: December 9, 2014
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Tengion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Neo-Urinary Conduit
Implantation with the autologous Neo-Urinary Conduit

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	The Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	The University of Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Procedure and/or product related adverse events post implantation	Evaluation of procedure and/or product related adverse events	through 12 months post implantation	Yes