NCT05396456招募中不适用
Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
研究概览
简要总结
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
详细描述
The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.
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
- •18 years of age
- •participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period
- •participants must score >10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
- •participants must have had symptoms for at least 12 months
- •participants who have failed standard medical and surgical treatments for FI
- •participant will undergo anorectal manometry (ARM) testing
- •participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees
- •women of childbearing potential must use acceptable contraceptives during this study
排除标准
- •participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage
- •participants with pre-existing ano-rectal pain of any cause
- •participants with incontinence of flatus only
- •chronic watery diarrhea which is the primary cause for fecal incontinence
- •acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)
- •presence of anorectal tumors
- •active proctitis or inflammatory bowel disease
- •previous injection of internal anal sphincter (IAS) with bulking agents
- •participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment
- •participants with a defined bleeding disorder diagnosed and treated by a hematologist
- •other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids
- •participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction
- •women who are pregnant, breastfeeding, or have had a child within the last year
- •participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr >1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C > 8 mg/dl)
- •participants with anemia (hemoglobin <10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times normal) or increased bilirubin >1.5mg/dl
- •participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2
- •rectal prolapse
- •vaginal prolapse beyond the hymen
- •unable to understand informed consent information even with provision of a medical translator
结局指标
主要结局
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
时间窗: Month 12
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
次要结局
- Rectal Anal Inhibitory Reflex (RAIR) Pressure scores(baseline, Months 3 and 12)
- Internal Anal sphincter (IAS) Pressure scores(baseline, Months 3 and 12)
- Change in Fecal Incontinence Quality of Life (FI-QOL) scores(baseline, Months 3 and 12)
- Anorectal Manometry (ARM) Pressure scores(baseline, Months 3 and 12)
- Fecal Incontinence Severity Index (FISI) scores(baseline, Months 3 and 12)
研究者
研究点 (2)
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