A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Tengion
- 入组人数
- 8
- 试验地点
- 11
- 主要终点
- Structural integrity and conduit patency
研究概览
简要总结
The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.
详细描述
The NUC under investigation is a regenerative medicine product comprised of the patient's own smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate culture conditions to reproducibly generate the necessary quantities of SMC in vitro from autologous adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing Practices (GMP) qualified clinical production facility. In this process, smooth muscle cells (SMC) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. At the end of this process, the SMCs are seeded onto the surface of a biodegradable PGA/PLGA mesh scaffold to form the NUC. The NUC is shipped to the investigative site for surgical implantation. Over time, the NUC should facilitate the regeneration of urinary tract tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 - 80 years of age
- •Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0
- •Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy
排除标准
- •History of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer)
- •Evidence of cancer metastasis
- •History of any pelvic radiation or non-pelvic radiation within past 5 years
- •Debilitating cardiac or pulmonary disease
- •Expected need for chemotherapy within 3 months post cystectomy
- •Life expectancy less than 2 years
结局指标
主要结局
Structural integrity and conduit patency
时间窗: 12 months post implantation
CT scan will be used to demonstrate that urine is able to flow safety through the NUC
次要结局
- Structural integrity and conduit patency(month 12 through month 60 post implantation)
- Procedure and/or product related AEs(month 12 through month 60 post implant)
- Overall safety(from enrollment through month 60 post implant)
- Procedure and/or product related adverse events post implantation(through 12 months post implantation)