Concomitant Renal and Urinary Bladder Allograft Transplantation

Exclusion Criteria

• •They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or
• •Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation)
• •Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
• •Subjects with a current positive (\>=5 mm induration for high-risk subjects; otherwise \>=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
• •Known history of hypersensitivity to aminoglycosides or fluoroquinolones
• •Use of any investigational product within 3 months
• •Prior participation in the study
• •Currently smoking
• •Current incarceration for any reason
• •Unwillingness, inability, or unlikely compliance of individual and/or primary caregiver with study related schedules procedures, management, or follow -up in the opinion of the PI and/or co-investigators
• •Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
• •Subjects with an ALT or AST value \>3 times the upper limit of normal
• •Subjects with acute or chronic abdominal skin infections and/or acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease
• •Subjects with uncontrolled diabetes defined as HgA1c\>10, unstable cardiac and/or pulmonary disorders, or bleeding disorders
• •Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk.
• •Surgical procedure for transplantation cannot be successfully performed for anatomical reasons
• •Life expectancy with successful transplantation is estimated to be \<5 years for any reason.
• •There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or
• •Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits/care after transplant, or
• •Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or
• •Hypertension stage II \> 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
• •Presence of severe coagulopathy, (hyper or hypo)
• •Patient is not up to date on current CDC recommended vaccines