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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 4 8}

Research Team

Inderbir Gill

Principal Investigator

University of Southern California

Eligibility Criteria

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 between 18 and 65 years old.

I am currently on medication to suppress my immune system.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Robot-Assisted Radical Cystectomy With Orthotopic Neobladder as a Urinary Diversion for a Kidney Transplant Recipient: A Case Report. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Combined kidney and vascularized total bladder transplantation: experience in an animal model. [2015]

5. Brazil pubmed.ncbi.nlm.nih.gov

Robotic Assisted Radical Cystoprostatectomy and Intracorporeal Ileal Conduit Urinary Diversion for a Kidney Transplant Recipient. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Biological vascularized matrix for bladder tissue engineering: matrix preparation, reseeding technique and short-term implantation in a porcine model. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Management of Bladder Cancer After Renal Transplantation. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. [2010]