Bladder CancerPhase 1NCT01087697
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
A Phase 1 study testing Neo-Urinary Conduit in people with Bladder Cancer, run by Tengion at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Neo-Urinary Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2010to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
The Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of Chicago
Chicago, Illinois, 60637
Baylor College of Medicine
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Neo-Urinary Conduit
- Keywords
- bladder cancer, radical cystectomy, incontinent urinary diversion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-Urinary ConduitDevice
Also called NUC
Implantation with the autologous Neo-Urinary Conduit
| Study group | Role | What they receive |
|---|---|---|
| Implanted with NUC | Experimental | Patients who have been implanted with the Neo-Urinary Conduit Receives: Device: Neo-Urinary Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural integrity and conduit patency
CT scan will be used to demonstrate that urine is able to flow safety through the NUC
Measured: 12 months post implantation
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: through 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tengion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Steinberg, MD, Principal investigator, University of ChicagoTrinity J Bivalacqua, M.D., Ph.D., Principal investigator, The Johns Hopkins Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087697
- Sponsor's protocol ID
- TNG-CL009
- Status last verified
- Dec 2014
- First submitted
- 15 Mar 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
- ClinicalTrials.gov ID
- NCT01087697
- Acronym / sponsor ID
- TNG-CL009
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, radical cystectomy, incontinent urinary diversion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- TengionIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted with NUC | Experimental | Device: Neo-Urinary ConduitPatients who have been implanted with the Neo-Urinary Conduit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-Urinary ConduitAlso: NUCImplantation with the autologous Neo-Urinary Conduit | Device | Implanted with NUC |
Primary outcome
Structural integrity and conduit patency
Time frame: 12 months post implantation
CT scan will be used to demonstrate that urine is able to flow safety through the NUC
4 secondary outcomes
Structural integrity and conduit patency
Time frame: month 12 through month 60 post implantation
Procedure and/or product related AEs
Time frame: month 12 through month 60 post implant
Overall safety
Time frame: from enrollment through month 60 post implant
Procedure and/or product related adverse events post implantation
Time frame: through 12 months post implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Steinberg, MD principal investigator
University of Chicago
Trinity J Bivalacqua, M.D., Ph.D. principal investigator
The Johns Hopkins Medical Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neo-Urinary Conduit in people with Bladder Cancer, run by Tengion at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural integrity and conduit patency (time frame: 12 months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.