Clinical Development of Tacrolimus for Hemorrhagic Cystitis

摘要 出血性膀胱炎(HC)是一种以膀胱出血和尿痛为特征的炎症性疾病。HC 是治疗骨盆区前列腺癌的放射治疗和化疗的并发症， 卵巢、宫颈、膀胱和结直肠。因为膀胱细胞周转缓慢，所以可以出现HC。 在这样的手术后几个月或几年，一旦发生HC，它往往会继续再次发生。HC可能会严重 降低患者的生活质量，需要长期的后续治疗，有时是致命的。确实有 目前没有FDA批准的治疗HC的疗法，也没有考虑大多数可用的治疗方案 有效。对于患有HC的老年患者来说，像膀胱切除术这样的侵入性治疗方案是不能容忍的。 HC的治疗代表着一种未得到满足的医疗需求。这项小型企业创新研究项目将 完成用于治疗HC的新产品的第一次临床试验。这项拟议的项目是 这是通向适销对路产品的关键一步，也是治疗丙型肝炎的第一个潜在疗法。

ABSTRACT Hemorrhagic cystitis (HC) is an inflammatory illness marked by bleeding in the bladder and urinary pain. HC is a complication of radiation therapy and chemotherapy used to treat cancers of the pelvic area—prostate, ovarian, cervical, bladder, and colorectal. Because the bladder exhibits slow cell-turnover, HC can emerge months or years after such procedures and once HC occurs, it often continues to re-occur. HC can severely degrade a patient's quality of life, require long-term follow-up treatment, and is sometimes fatal. There are currently no FDA approved therapies to treat HC and most available treatment options are not considered effective. Invasive treatments options like bladder cystectomy are not tolerable for older patients with HC. The treatment of HC represent an unmet medical need. This Small Business Innovative Research project will complete the first clinical trial for a new product indicated for the treatment of HC. This proposed project is a critical step leading to a marketable product and the first potential treatment for HC.