Treatment (VCBA) for Urinary Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
USC / Norris Comprehensive Cancer Center, Los Angeles, CA
Urinary Bladder Cancer+3 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This early phase I trial tests the feasibility, functionality, and sustainability of robotic vascularized composite bladder allograft transplantation in treating patients with bladder cancer. A vascularized bladder allograft transplantation may provide a more durable and better tolerated alternative to urinary diversion using bowel in patients with bladder cancer.

Eligible Conditions

  • Urinary Bladder Cancer
  • Muscle Invasive Bladder Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: At 7, 30, and 90 days

Day 90
Bladder function
At completion of transplantation procedure
Technical success of vascularized composite bladder allograft (VCBA) transplantation
Day 90
Adverse events associated with VCBA transplantation
Year 1
Acute transplant rejection
Delayed transplant rejection

Trial Safety

Trial Design

1 Treatment Group

Treatment (VCBA)
1 of 1
Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (VCBA) · No Placebo Group · N/A

Treatment (VCBA)Experimental Group · 2 Interventions: Quality-of-Life Assessment, Vascularized Autograft · Intervention Types: Other, Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 7, 30, and 90 days
Closest Location: USC / Norris Comprehensive Cancer Center · Los Angeles, CA
Photo of Los Angeles  1Photo of Los Angeles  2Photo of Los Angeles  3
2010First Recorded Clinical Trial
0 TrialsResearching Urinary Bladder Cancer
126 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have bladder cancer that is localized, non-metastatic, muscle-invasive (cT2 or T3) requiring radical cystectomy.
Patients that are on immunosuppression for pre-existing solid organ transplantation will be included in this study.
Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.