Stem Cells Therapy for Fecal Incontinence in Children After Posterior

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT02161003
Study type	Interventional
Source	Al-Azhar University
Contact	Refaat Ibrahiem El-Badawy
Phone	+201001567863
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	October 2013
Completion date	December 2016

View Details

See also
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Withdrawn	`NCT02208258` - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.	N/A
Completed	`NCT01939821` - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes	N/A
Completed	`NCT01957969` - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Recruiting	`NCT00530933` - Tibial Nerve Stimulation for Faecal Incontinence	N/A
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Completed	`NCT03746834` - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation	Phase 4
Completed	`NCT00124904` - Biofeedback for Fecal Incontinence	N/A
Completed	`NCT03028636` - LIBERATE - PRO: Eclipse™ System Registry
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1
Completed	`NCT05621629` - Management of FI After Surgery of ARM
Withdrawn	`NCT04138602` - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms