Phase 1 Treatment Study to Assess Safety and Proof of Concept to Assess Potential Efficacy of the Implanted Internal Anal Sphincter BioSphincterTM Bioengineered From Autologous Cells to Treat Patients With Severe Passive Fecal Incontinence
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events of Implanted BioSphincter IAS for patients with severe FI Who Have Failed Standard Treatment
研究概览
简要总结
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.
详细描述
This is a two-center first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments. The data will be analyzed to assess the safety of the treatment and the potential initial efficacy of the implanted BioSphincter(TM) in decreasing the number of episodes of incontinence in subjects with severe FI.
After being informed of the risks, informed consent patients will undergo a biopsy procedure to collect tissue samples and will then undergo an implantation surgery of the bioengineered BioSphincter(TM). Patients will be followed for 36 months, post implantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Implantation
This is a non-randomized, single group treatment study with a single arm and is not subject or investigator masked or blinded. BioSphincters will be implanted in every study subject.
干预措施: Bioengineered Internal Anal Sphincter (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events of Implanted BioSphincter IAS for patients with severe FI Who Have Failed Standard Treatment
时间窗: 12-36 months
To determine the safety of IAS cell harvest and the implanted BioSphincter IAS in subjects with severe FI. Occurrence of adverse events. * Occurrence, severity, duration, and relationship to study procedures. * The safety of all surgical and diagnostic procedures will be assessed at inpatient hospital follow-up and outpatient clinic visits at predefined intervals. * Biopsy: Site of IAS cell harvest will be assessed postoperatively at Days 1, 7, and 21. * BioSphincter implantation will be assessed postoperatively at postoperative Days 1, 3, 7, 14, 28, 42 (week 6) and 56 (week 8). Additional safety assessments will be made at medical visits on Weeks 12, 24, 36 and 48-post implantation. Final safety assessments will be made a.t the end of Years 2 and 3
次要结局
- Initial efficacy of the implanted IAS in decreasing the number of episodes of fecal urgency in subjects with severe FI.(12-48 weeks)
- Change from Baseline CCIS Score of the implanted IAS in improving quality of life(12-48 weeks)
- Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring IAS pressure to support measured clinical changes(0-36 months)
- Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring sensation of balloon distention pressure to support measured clinical changes(0-36 months)
- Change from Baseline FIQOL Score of the implanted IAS in improving quality of life(12-48 weeks)
- Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring presence of RAIR to support measured clinical changes(0-36 months)
- Measure Physical characteristics of the Bioengineered Sphincter as assessed by endoscopic ultrasound (EUS)(0-36 months)
- Initial efficacy of the implanted IAS in decreasing the number of episodes of incontinence in subjects with severe FI.(12-48 weeks)
- Change from Baseline FISI Score of the implanted IAS in improving quality of life(12-48 weeks)
- Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring EAS pressure to support measured clinical changes(0-36 months)