Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Main outcome measures
研究概览
简要总结
The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare cost, as well as loss of productivity in the work force. Fecal incontinence treatment has been a difficult challenge for surgeons for several generations until now the current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury of muscle of anal sphincter in rats has been successfully treated with stem cells injections. In this study, the investigators will shed more light on the ability of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence. It will be very useful to many Egyptian patients.
详细描述
A stem cell is capable of forming various tissue under definite signals received from the body. Stem cell research in animals has been an ongoing program in the west with fruitful results. Current challenges with the use of stem cells in clinical practice will be solve the many unanswered queries. To study the potential therapeutic effects of local Mesenchymal Stem cell injection in children presenting with fecal incontinence (FI) after posterior sagittal ano-rectoplasty (PSARP) operation for high imperforate anus. Children whom suffering from FI after PSARP for high imperforate anus will included in this study. Autologous MSC from the upper posterior iliac crest bone marrow sample will be extracted from patients under general anesthesia, in a suitable clean operation room. Will be Cultured and injected into the external anal sphincter defect using direct pena stimulator or ultra sound guidance. Then followed up for 180 days post injection, to assess the ability of mesenchymal stem cells to induce myogenesis of the anal Sphincter of patients with FI after PSARP.
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
- 2 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Childern Ages: above 2 Years old.
- •Patient with FI. After PSARP repair of high imperforate anus.
- •Absence of parasitic and infective bacterial growth after Stool analysis and stool culture.
排除标准
- •Any degree of Spinal cord injury, systemic, neuronal paralysis or sacral agenesis.
- •Absence of muscle activity detected by EMG.
- •Ano-rectal disorders such as tumors, fissures, anal or rectal prolapse, and rectocele.
- •Positive stool culture resistant to preoperative oral antibiotic therapy.
- •Previous injection of bulking agents at the level of sphincter.
- •Immunocompromise patient.
- •Previous adverse reaction to anesthesia.
结局指标
主要结局
Main outcome measures
时间窗: 24 Weeks
Incontinence Score
次要结局
- Assessment of Clinical Parameters(24 Weeks)
- Clinical Assessment(24 Weeks)
- Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)(48 Weeks)
研究者
Sayed Bakry
Associate Professor - Consultant of Isolation and Culturing of Stem Cells
Al-Azhar University