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

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.

Study Overview

• Status: Unknown
• Conditions: Fecal Incontinence
• Intervention / Treatment: Procedure: Stem Cells Injection Technique; Procedure: Stem Cell Isolation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Nasr City, Cairo, Egypt
      • Recruiting
      • Pediatric Surgery Outpatients Clinics - Al Hussien Hospital
      • Contact: Contact: Abdel-Wahab El-Okby, MD; Phone Number: +201001478100
      • Sub-Investigator: Refaat Ibrahiem El-Badawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stem Cells Isolation; Stem cell isolation technique and Stem Cells Injection Technique The method of isolation of MSC from bone marrow will be carried out using the Ficoll-Paque technique for the isolation of mononucleated cells followed by the separation of MSC by adherence to plastic. Finally, the cells will be resuspended and counted using a hemocytometer. Mononucleated cells will be cultured and incubated at 37°C in an atmosphere of 95% relative humidity and 5% CO2.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main outcome measures	Incontinence Score	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Clinical Parameters	This Including: Clinical Assessment. Continence score.	24 Weeks
Clinical Assessment	Maximum dry interval per day will be measured after injection at day 1, 30 and 90.	12 Weeks
Clinical Assessment	MRI pelvic floor muscles study will be done after 90 days post injection.	24 Weeks
Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)	EMG study will be done after 90, 180 days post injection.	48 Weeks

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Cairo University; Ain Shams University; Wake Forest University Health Sciences; Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Study Director: Sayed Bakry, PhD, Al-Azhar University; Study Chair: Hala Gabr, MD, Cairo University; Principal Investigator: Abdel-Wahab El-Okby, MD, Al-Azhar University; Study Chair: Naglaa Ali Gadallah, MD, Ain Shams University; Study Chair: Refaat El-Badawy, MD, Al-Azhar University; Study Chair: Wael Wael Abu El Khier, MD, Military Academy; Study Chair: Anthony Atala, MD, Director of the Wake Forest Institute for Regenerative Medicine; Study Chair: Mostafa Elbahrawy, MSc, Al-Azhar University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: June 8, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): June 11, 2014
• Last Update Submitted That Met QC Criteria: June 8, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Mesenchymal Stem Cell; Fecal Incontinence; Posterior Sagittal Ano-rectoplasty
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: Azhar52980070 (Other Grant/Funding Number: Al Azhar University)