NCT02161003

Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty

Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Male
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
PROCEDURE	Stem Cells Injection Technique	Injection of MSCs for the treatment of anal sphincter insufficiency is a potential alternative therapy for imperforate anus patients who have undergone primary PSARP with post-operative FI. In this study a single dose of 1.2 ml MSC will be divided into 12 part of 0.1ml of MSC, doses will be injected into the anal sphincter all around in 12 injection sites according to the clock meridian under general anesthesia without giving muscle relaxant.
PROCEDURE	Stem Cell Isolation	From the upper posterior iliac crest 10 ml bone marrow sample will be extracted from patients using a heparinized syringe, under general anesthesia, in a suitable clean operation room.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2014-06-11
• Last updated: 2014-06-11

Locations

1 site across 1 country: Egypt