Vascularized Composite Bladder Allograft Transplantation

NCT05462561 | Recruiting

• 3 other identifiers: 4B-21-5NCI-2022-00076P30CA014089
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunosuppression; Neurogenic Bladder; Bladder Dysfunction

Keywords

neurogenic bladder; vascularized composite allograft

Outcome Measures

Primary Outcomes (1)

• Technical success of vascularized composite bladder allograft (VCBA) transplantation

  Defined as appropriate vascularization of the transplanted bladder, measured through intraoperative fluorescence imaging and immediate post-operative computed tomographic angiography.

  At completion of transplantation procedure

Secondary Outcomes (3)

• Adverse events associated with VCBA transplantation

  Immediately peri-operative and 30 and at 90 days after transplantation

• Transplant rejection

  Up to 1 year within 7 days post-transplantation

• Bladder function

  At 7, 30, 90, 180, and 360 days

Study Arms (1)

Treatment (VCBA)

EXPERIMENTAL

Patients undergo robotic VCBA transplantation.

Other: Quality-of-Life Assessment; Procedure: Robotic Vascularized Composite Bladder Allograft Transplantation

Interventions

Robotic Vascularized Composite Bladder Allograft Transplantation PROCEDURE

Undergo robotic VCBA transplantation.

Treatment (VCBA)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (VCBA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Positive history of one of the following:
• Bladder pathology resulting in poor compliance, recurrent infections, and/or resultant upper tract (kidney and ureteral) pathology, demonstrated by hydronephrosis with resultant kidney disease.
• Localized, non-metastatic, muscle-invasive or lesser urothelial cell carcinoma of the bladder that requires therapeutic radical cystectomy will be considered only if the patient is already on pre-existing immunosuppression or who are expected candidates for immunosuppression in the near future, and then on a case-by-case basis after thorough evaluation and presentation to institutional tumor board committee. A minority of accrued patients are expected to have bladder cancer as the etiology of their cystectomy.
• Patients that are on pre-existing immunosuppression will be included in this study.
• Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.
• Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.

You may not qualify if:

• No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
• Negative crossmatch with donor.
• DONOR: Any potential brain dead donor considered for solid organ transplant.
• DONOR: Age 18-65 years.
• DONOR: Stable, meaning no requirement of excessive vasopressors for maintaining blood pressure.
• DONOR: ABO compatibility.
• DONOR: Negative cross-match with recipient.
• Positive history of one of the following medical co-morbidities:
• Human immunodeficiency virus \[HIV\] (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus.
• Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thallassemia, sickle cell disease.
• Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including:
• Mixed connective tissue disorder
• Severe deforming rheumatoid arthritis
• Infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy
• Ehler-Danlos syndrome

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Inderbir Gill

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ileana Aldana

CONTACT

323-865-0702; Ileana.aldana@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 5 total: * 1 patient will be accrued for feasibility, and monitored for a period of 3 months. * If successful, defined as the absence of life-threatening complication, including allograft rejection requiring explantation, and adequate bladder storage, accrual of the remaining 4 patients will ensue.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): October 3, 2027
• Study Completion (Estimated): October 3, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)