Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

Tengion8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

Neo-Urinary ConduitDEVICE

Implantation with the autologous Neo-Urinary Conduit

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

The University of Chicago

Chicago, Illinois, United States

The Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Structural integrity and conduit patency

CT scan will be used to demonstrate that urine is able to flow safety through the NUC

Time frame: 12 months post implantation

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: through 12 months post implantation

Data from ClinicalTrials.gov

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