The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis

Inclusion Criteria: Males and females, at least 18 years * History of sterile moderate to severe HC (Grade 2-4) for at least 3 months documented in the medical record with at least 1 episode of macroscopic hematuria with or without clot * Previous use of medications and/or treatment(s) for HC without success * Patients of child-bearing capability agree to use a reliable form of birth control (condoms and/or oral contraceptives) during the course of instillation therapy and for 1 week thereafter * Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the 3 day Hemorrhagic Cystitis Diary (HC Diary) and self-administered questionnaires Exclusion Criteria: * History of interstitial cystitis/painful bladder syndrome * HC due to infection (bacterial, viral or fungal) * Vesicoureteral reflux disease based on cystogram within past 12 months * Subject is currently or has previously participated in another therapeutic or device study within 3 months of screening and has not returned to baseline * Pregnant or lactating * History of bleeding diathesis or active bleeding peptic ulcer disease * Life expectancy less than 12 months * PSA \> 10.0 ng/dl (measured within the last 3 months) * Known allergy to liposomes and/or egg yolk and/or tacrolimus * Urinary retention requiring daily catheterization * Previous augmentation cystoplasty * Subjects currently taking prescribed treatment for HC will be able to continue the tre…