Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study

Exclusion Criteria

• •Positive history of one of the following medical co-morbidities:
• •1. HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus
• •2. 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, thalassemia, sickle cell disease.
• •3. 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; Ehlers-Danlos syndrome;
• •4. lipopolysaccharidosis or amyloidosis (effects nerve regeneration)
• •5. Impaired liver function as evaluated by liver function panel, including the presence of hyperbilirubinemia, elevated AST/ALT, and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.
• •6. Severe anemia (hemoglobin \< 7 g/dL), leukopenia (WBC \< 3 x 109 cell/L), or thrombocytopenia (platelets \< 20 x109 cells/L).
• •Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.
• •Oncology patient specific:
• •1. History of non-urothelial malignancy in past 5 years, with the exception of non-melanomatous skin cancer
• •2. History of malignancy involving metastases
• •Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
• •Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
• •Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.
• •Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting. In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made.