5 Participants Needed

Robotic Bladder Transplant for Bladder Cancer

IA
Overseen ByIleana Aldana
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
Must be taking: Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that patients on pre-existing immunosuppression can participate, suggesting that some medications may be continued. It's best to discuss your specific medications with the trial team.

Is robotic bladder transplant generally safe in humans?

There is currently no safety data available for robotic bladder transplant in humans, as it has not yet been performed. Existing studies have only explored the feasibility and technical aspects in preclinical and animal models.12345

How is the Robotic Vascularized Composite Bladder Allograft Transplantation treatment different from other bladder cancer treatments?

This treatment is unique because it involves transplanting a whole bladder using robotic assistance, which has never been done in humans before. It aims to replace the bladder entirely, unlike other treatments that may only remove cancerous parts or use chemotherapy.12467

What data supports the effectiveness of the treatment Robotic Vascularized Composite Bladder Allograft Transplantation for bladder cancer?

Preclinical studies have shown that robotic techniques can be used to perform complex bladder surgeries, such as bladder autotransplantation and vascularized composite bladder allograft transplantation, in preparation for human trials. Additionally, robotic-assisted surgeries have been successfully used in complex cases involving bladder cancer and kidney transplant recipients, suggesting potential effectiveness in similar complex surgical scenarios.12468

Who Is on the Research Team?

IG

Inderbir Gill

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with severe bladder issues needing a radical cystectomy, already on immunosuppression or will be soon. They must be able to perform self-catheterization and commit to the treatment plan. Excluded are those with HIV/AIDS, active hepatitis B/C, certain infections, poor medical compliance, substance abuse issues, recent non-urothelial malignancy history or without need for future immunosuppression.

Inclusion Criteria

I am committed to following the treatment plan as directed.
I am currently on medication to suppress my immune system.
My blood type matches the donor's.
See 8 more

Exclusion Criteria

I have had surgery on my bladder or prostate.
I have an abnormal bladder capacity.
The donor has tested positive for Hepatitis C virus (HCV) antibodies or has a detectable viral load.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Robotic VCBA transplantation is performed, followed by close inpatient monitoring for surgical complications and signs of rejection.

1-3 weeks
Daily examinations and post-operative ultrasound evaluations

Post-operative Follow-up

Participants are monitored for transplant success, rejection, and adverse events. Includes routine graft biopsies and cystoscopic evaluations.

12 months
Weekly visits for the first month, bi-weekly for the second month, monthly for 6 months, then every 3 months

Long-term Follow-up

Continued monitoring of bladder function and management of immunosuppression.

Ongoing beyond 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Robotic Vascularized Composite Bladder Allograft Transplantation
Trial Overview The study tests robotic vascularized composite bladder allograft transplantation as an alternative to standard urinary diversion in patients with terminal bladder pathology. It aims to assess if this new method is feasible and sustainable compared to traditional techniques using bowel tissue.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (VCBA)Experimental Treatment2 Interventions
Patients undergo robotic VCBA transplantation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

This study successfully developed a technique for robotic retrieval and autotransplantation of vascularized bladder allografts in preclinical models, including living pigs and human cadavers, paving the way for future human trials.
The procedure demonstrated technical success with healthy revascularized autografts and maintained vascularity in heart-beating brain-dead donors, indicating the potential for safe and effective bladder transplantation in humans.
Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant.Nassiri, N., Cacciamani, G., Gill, IS.[2023]
The study demonstrated that urinary bladder vascularized composite allograft transplantation is technically feasible, as shown by successful mock transplants in two adult cadavers, indicating potential for future clinical applications.
This innovative approach could provide an alternative to using intestinal segments for bladder reconstruction, which may improve patient outcomes and reduce complications associated with intestinal grafts.
Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model.Gargollo, PC., Ahmed, ME., Prieto, M., et al.[2021]
A robot-assisted radical cystectomy was successfully performed on a kidney transplant recipient with invasive bladder cancer, demonstrating the feasibility of this approach in patients with urinary tract abnormalities.
Despite experiencing a postoperative complication (an intraperitoneal infection), the patient's condition improved with antibiotic treatment, highlighting the potential safety and effectiveness of robot-assisted surgery in complex cases.
Robot-Assisted Radical Cystectomy With Orthotopic Neobladder as a Urinary Diversion for a Kidney Transplant Recipient: A Case Report.Ishiyama, Y., Yoshida, K., Iizuka, J., et al.[2020]

Citations

Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. [2023]
Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. [2021]
Robot-Assisted Radical Cystectomy With Orthotopic Neobladder as a Urinary Diversion for a Kidney Transplant Recipient: A Case Report. [2020]
Combined kidney and vascularized total bladder transplantation: experience in an animal model. [2015]
Robotic Assisted Radical Cystoprostatectomy and Intracorporeal Ileal Conduit Urinary Diversion for a Kidney Transplant Recipient. [2018]
Biological vascularized matrix for bladder tissue engineering: matrix preparation, reseeding technique and short-term implantation in a porcine model. [2022]
Management of Bladder Cancer After Renal Transplantation. [2018]
The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. [2010]
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