Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
This study is currently recruiting participants.
Verified April 2013 by Tengion
Sponsor:
Tengion
Information provided by (Responsible Party):
Tengion
ClinicalTrials.gov Identifier:
NCT01087697
First received: March 15, 2010
Last updated: May 2, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Device: Neo-Urinary Conduit |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by Tengion:
Primary Outcome Measures:
- Structural integrity and conduit patency [ Time Frame: 12 months post implantation ] [ Designated as safety issue: Yes ]CT scan will be used to demonstrate that urine is able to flow safety through the NUC
Secondary Outcome Measures:
- Structural integrity and conduit patency [ Time Frame: month 12 through month 60 post implantation ] [ Designated as safety issue: Yes ]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 [ Time Frame: month 12 through month 60 post implant ] [ Designated as safety issue: Yes ]procedure and/or product related AEs will be evaluated through month 60 post implantation
- Overall safety [ Time Frame: from enrollment through month 60 post implant ] [ Designated as safety issue: Yes ]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 [ Time Frame: through 12 months post implantation ] [ Designated as safety issue: Yes ]Evaluation of procedure and/or product related adverse events
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Implanted with NUC
Patients who have been implanted with the Neo-Urinary Conduit
|
Device: Neo-Urinary Conduit
Implantation with the autologous Neo-Urinary Conduit
Other Name: NUC
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087697
Contacts
| Contact: William S Aronstein, PhD, MD | 513 598-9290 | baronstein@ctifacts.com |
| Contact: Brian C Johnston | 513 598-9290 | bjohnston@ctifacts.com |
Locations
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Gary Steinberg, MD 773-702-3080 gsteinbe@surgery.bsd.uchicago.edu | |
| Contact: Ann Strasbaugh, RN 773 702-0792 astrasbau@surgery.bsd.uchicago.edu | |
| Principal Investigator: Gary Steinberg, MD | |
| United States, Maryland | |
| The Johns Hopkins Medical Institutions | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Trinity Bivalacqua, MD 410-955-6100 tbivala1@jhmi.edu | |
| Contact: Abby Booker 410 955-6100 abooker4@jhmi.edu | |
| Principal Investigator: Trinity Bivalacqua, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Kevin Loughlin, MD, MBA 617-525-7603 kloughlin@partners.org | |
| Contact: Michael Myers 617-525-7723 mmeyers@pchi.partners.org | |
| Principal Investigator: Kevin Loughlin, MD, MBA | |
| United States, Michigan | |
| University of Michigan Health System | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Cheryl T Lee, MD 734-615-6662 ctlee@med.umich.edu | |
| Contact: Jean Humrich 734-232-4863 jeo@med.umich.edu | |
| Principal Investigator: Cheryl T Lee, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Bernard Bochner, MD 646-422-4387 bochnerb@mskcc.org | |
| Contact: Dahlia Sperling 646-227-2329 sperlind@mskcc.org | |
| Principal Investigator: Bernard Bochner, MD | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Seth Lerner, MD 713-790-3311 slerner@bcm.edu | |
| Contact: Helen A Kopelen 713-798-8514 kopelen@bcm.edu | |
| Principal Investigator: Seth Lerner, MD | |
Sponsors and Collaborators
Tengion
Investigators
| Principal Investigator: | Gary Steinberg, MD | University of Chicago |
| Principal Investigator: | Trinity J Bivalacqua, M.D., Ph.D. | The Johns Hopkins Medical Institute |
More Information
No publications provided
| Responsible Party: | Tengion |
| ClinicalTrials.gov Identifier: | NCT01087697 History of Changes |
| Other Study ID Numbers: | TNG-CL009 |
| Study First Received: | March 15, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tengion:
|
bladder cancer radical cystectomy incontinent urinary diversion |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013