Clinical Development of Tacrolimus for Hemorrhagic Cystitis

他克莫司治疗出血性膀胱炎的临床进展

• 批准号: 9345180
• 负责人: JONATHAN H KAUFMAN
• 金额: $ 51.42万
• 依托单位: LIPELLA PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-12 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9345180
• 关键词: Aftercare; Animal Model; Anti-Inflammatory Agents; Area; Biological Products; Bladder; Businesses; Cancer Patient; Caring; Catheters; Cells; Cervical; Clinical; Clinical Research; Clinical Trials; Colorectal; Complement; Complication; Cystectomy; Cystitis; Data; Dose; Double-Blind Method; Enrollment; Exhibits; FDA approved; Formulation; Frequencies; Funding; Hematuria; Hemorrhage; Human; Immunosuppressive Agents; Inflammatory; Intellectual Property; Investigational Drugs; Life; Liposomes; Marketing; Medical; Methodology; Monitor; Multicenter Trials; Orphan Drugs; Outcome; Ovarian; Pain; Patient Care; Patients; Pelvic Cancer; Pelvis; Pharmacologic Substance; Phase; Placebo Control; Procedures; Program Development; Property Rights; Prostate; Public Health; Quality Control; Quality of life; Radiation; Radiation therapy; Randomized; Reporting; Research Contracts; Research Project Grants; Rights; Safety; Site; Small Business Innovation Research Grant; Symptoms; Tacrolimus; Testing; United States; bladder pain; cancer therapy; chemotherapy; clinical development; controlled release; cost; follow-up; improved; innovation; irritation; lower urinary tract symptoms; medical specialties; meetings; novel therapeutics; older patient; oncology; operation; product development; prospective; survival outcome; urinary; urologic

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.

摘要 出血性膀胱炎（HC）是一种炎症性疾病，以膀胱出血和尿路疼痛为特征。HC 是用于治疗骨盆区域前列腺癌的放射疗法和化学疗法的并发症， 卵巢、宫颈、膀胱和结肠直肠。由于膀胱表现出缓慢的细胞更新，HC可以出现 在这些手术后数月或数年，并且一旦HC发生，它经常继续复发。HC可以严重 降低患者的生活质量，需要长期随访治疗，有时是致命的。有 目前没有FDA批准的治疗HC的疗法，并且大多数可用的治疗选择都没有考虑 有效对于患有HC的老年患者来说，诸如膀胱癌的侵入性治疗选择是不可耐受的。 HC的治疗代表未满足的医疗需求。这个小企业创新研究项目将 完成用于治疗HC的新产品的首次临床试验。该项目是 这是一个关键的步骤，导致一个可销售的产品和第一个潜在的治疗HC。