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

NCT02161003 | Unknown Phase 1 DMC

• 1 other identifier: Azhar52980070
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence; Posterior Sagittal Ano-rectoplasty; Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (1)

• Main outcome measures

  Incontinence Score

  24 Weeks

Secondary Outcomes (4)

• Assessment of Clinical Parameters

  24 Weeks

• Clinical Assessment

  12 Weeks

• Clinical Assessment

  24 Weeks

• Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)

  48 Weeks

Study Arms (1)

Stem Cells Isolation

EXPERIMENTAL

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; Procedure: Stem Cell Isolation

Interventions

Stem Cells Injection Technique PROCEDURE

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 Cells Isolation

Stem Cell Isolation PROCEDURE

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.

Stem Cells Isolation

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead
• Cairo University: collaborator
• Ain Shams University: collaborator
• Affiliated Hospital to Academy of Military Medical Sciences: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Pediatric Surgery Outpatients Clinics - Al Hussien Hospital

Madīnat an Naşr, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Abdel-Wahab El-Okby, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Naglaa Ali Gadallah, MD

  Ain Shams University

  STUDY CHAIR

• Sayed Bakry, PhD

  Al-Azhar University

  STUDY DIRECTOR

• Refaat El-Badawy, MD

  Al-Azhar University

  STUDY CHAIR

• Hala Gabr, MD

  Cairo 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 CHAIR

Central Study Contacts

Refaat Ibrahiem El-Badawy

CONTACT

+201001567863

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Consultant of Isolation and Culturing of Stem Cells

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: June 11, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

EG (1)