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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02161003
• Other study ID #: Azhar52980070
• Secondary ID: Azhar52980070
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 9, 2014
• Last updated: June 8, 2014
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2014
• Source: Al-Azhar University
• Contact: Refaat Ibrahiem El-Badawy
• Phone: +201001567863
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher EducationEgypt: Ministry of Health and Population
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Pediatric Surgery Outpatients Clinics - Al Hussien Hospital	Nasr City	Cairo

Sponsors (5)

Lead Sponsor	Collaborator
Al-Azhar University	Affiliated Hospital to Academy of Military Medical Sciences, Ain Shams University, Cairo University, Wake Forest School of Medicine

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome measures	Incontinence Score	24 Weeks	Yes
Secondary	Assessment of Clinical Parameters	This Including: Clinical Assessment. Continence score.	24 Weeks	Yes
Secondary	Clinical Assessment	Maximum dry interval per day will be measured after injection at day 1, 30 and 90.	12 Weeks	Yes
Secondary	Clinical Assessment	MRI pelvic floor muscles study will be done after 90 days post injection.	24 Weeks	Yes
Secondary	Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)	EMG study will be done after 90, 180 days post injection.	48 Weeks	Yes