Robotic Bladder Transplant for Bladder Cancer

Overseen By Ileana Aldana

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must be taking: Immunosuppressants

Disqualifiers: HIV, Hepatitis B/C, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat serious bladder problems using a robotic bladder transplant (Robotic Vascularized Composite Bladder Allograft Transplantation). The researchers aim to determine if this approach is more effective and less burdensome for patients than the usual method, which uses parts of the bowel for urinary diversion. It targets individuals with severe bladder issues, such as poor function, repeated infections, or bladder cancer that hasn’t spread. Those with a history of these conditions and who are willing to adhere to a strict treatment plan might be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to pioneering research that could lead to innovative treatments for bladder conditions.

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.

What prior data suggests that this robotic surgical approach is safe for bladder transplantation?

Research shows that the robotic bladder transplant remains in the early testing stages. The main focus has been on assessing the procedure's effectiveness and durability, rather than gathering extensive safety data. Early studies suggest promise, with the first successful bladder transplant demonstrating feasibility. However, detailed safety information remains limited, as the procedure is still under exploration in initial trials. As an experimental procedure, safety findings continue to develop as more data emerges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robotic Vascularized Composite Bladder Allograft Transplantation is unique because it uses robotics to perform a bladder transplant, which is not a standard approach for treating bladder cancer. Traditional treatments often include surgery, chemotherapy, or radiation, but this method involves replacing the diseased bladder with a healthy one from a donor. Researchers are excited because the robotic technique could offer more precision and potentially speed up recovery times. This innovative approach might provide a new treatment option for patients who have not responded well to existing therapies.

What evidence suggests that robotic vascularized composite bladder allograft transplantation is effective for bladder cancer?

This trial will evaluate the use of robotic surgery to transplant a new bladder, known as Robotic Vascularized Composite Bladder Allograft Transplantation, as a treatment for bladder cancer. Research has shown that this method is promising, with early studies indicating successful implementation. The procedure uses a robot to assist in transplanting a bladder ready to connect with the body's blood vessels, potentially leading to better long-term results and fewer side effects compared to traditional methods using parts of the bowel. Preclinical studies have demonstrated the feasibility of this technique, paving the way for more advanced trials. Although still in the early stages, this new treatment aims to improve the quality of life for patients with serious bladder issues. ^{1 2 5 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Treatment (VCBA) Experimental Treatment 2 Interventions

Patients undergo robotic VCBA transplantation.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. Nassiri, N., Cacciamani, G., Gill, IS.[2023]

The study demonstrated that vascularized total bladder transplantation alongside kidney transplantation is feasible, as all grafts showed good blood supply and normal oxygen saturation during the observation period.

While one recipient experienced thrombosis leading to reduced urinary output, the other two recipients maintained normal bladder function, suggesting that with careful monitoring, this procedure could serve as a viable option for bladder augmentation or replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined kidney and vascularized total bladder transplantation: experience in an animal model. Torino, G., Capozza, N., Diomedi Camassei, F., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. Gargollo, PC., Ahmed, ME., Prieto, M., et al.[2021]

The study successfully created a vascularized bladder substitute using a decellularized porcine small bowel matrix, which was reseeded with bladder smooth muscle cells and urothelial cells, showing effective cell growth and integration.

Implantation of the graft with endothelial progenitor cells (EPCs) maintained vascular perfusion and prevented thrombosis, demonstrating that EPC reseeding is crucial for the graft's immediate vascular function and potential long-term viability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological vascularized matrix for bladder tissue engineering: matrix preparation, reseeding technique and short-term implantation in a porcine model. Schultheiss, D., Gabouev, AI., Cebotari, S., et al.[2022]

Robotic assisted radical cystectomy (RARC) with intracorporeal ileal conduit urinary diversion was successfully performed on a 60-year-old renal transplant recipient with high-grade muscle invasive bladder cancer, demonstrating the feasibility of this approach for complex cases.

The surgery had no intraoperative or postoperative complications, with an operative time of 443 minutes and a hospital stay of 5 days, indicating that RARC can be a safe and effective option for patients with prior renal transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Assisted Radical Cystoprostatectomy and Intracorporeal Ileal Conduit Urinary Diversion for a Kidney Transplant Recipient. Caputo, PA., Ramirez, D., Maurice, M., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Robot-assisted radical cystectomy (RARC) is a minimally invasive procedure for invasive bladder cancer, showing a mean operative time of 386 minutes and an estimated blood loss of 408 ml across 496 patients studied from 2003 to 2009.

The study identified that achieving proficiency in RARC, indicated by low positive surgical margin rates, typically requires performing at least 30 cases, suggesting that this number is crucial for surgeons to reach an acceptable level of skill in this complex procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Hayn, MH., Hussain, A., Mansour, AM., et al.[2010]

Radical cystectomy (RC) and ileal conduit urinary diversion can be safely performed in renal transplant recipients, as demonstrated by two cases with no perioperative or postoperative complications.

Both patients underwent the procedures several years after their kidney transplants, indicating that this surgical approach is feasible even in those with a history of renal transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Bladder Cancer After Renal Transplantation. Demirdag, C., Citgez, S., Talat, Z., et al.[2018]

Citations

1. cancer.gov cancer.gov/clinicaltrials/NCI-2022-00076

Robotic Vascularized Composite Bladder Allograft ... This early phase I trial tests the feasibility, functionality, and sustainability of robotic vascularized composite bladder allograft transplantation in ...

2. bcan.org bcan.org/clinicaltrials/robotic-vascularized-composite-bladder-allograft-transplantation-surgery-for-the-treatment-of-patients-with-bladder-cancer/

Robotic Vascularized Composite Bladder Allograft ... This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37681535/

Robotic Bladder Autotransplantation: Preclinical Studies in ... We report preclinical studies to develop the technique of robotic retrieval and autotransplantation of vascularized composite bladder allograft.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306987725002348

Decellularization of urinary bladder autograft in the ... At present, there are three ongoing clinical trials of vascularized composite urinary bladder allograft transplantation − NCT04626167, ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000001699

Feasibility Study of Vascularized Composite Urinary ... The purpose of this study was to establish the feasibility of performing a urinary bladder vascularized composite allograft transplantation for either bladder ...

6. trialx.com trialx.com/clinical-trials/listings/282557/vascularized-composite-bladder-allograft-transplantation/?&geo_lat=33.9775142&geo_lng=-118.1870156&radius=10&place=Bell&user_country=United%20States

Vascularized Composite Bladder Allograft Transplantation This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in ...

7. renalandurologynews.com renalandurologynews.com/features/first-bladder-transplant/

First Bladder Transplant Offers New Hope for Patients ... The first bladder transplant in a living patient is the successful result of years of research and surgical innovation.