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Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

NCT ID: NCT01087697

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Keywords

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bladder cancer radical cystectomy incontinent urinary diversion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implanted with NUC

Patients who have been implanted with the Neo-Urinary Conduit

Group Type EXPERIMENTAL

Neo-Urinary Conduit

Intervention Type DEVICE

Implantation with the autologous Neo-Urinary Conduit

Interventions

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Neo-Urinary Conduit

Implantation with the autologous Neo-Urinary Conduit

Intervention Type DEVICE

Other Intervention Names

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NUC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tengion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Trinity J Bivalacqua, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins Medical Institute

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

The Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TNG-CL009

Identifier Type: -

Identifier Source: org_study_id