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

• ClinicalTrials.gov Identifier: NCT02161003
• Recruitment Status: Unknown
• First Posted: June 11, 2014
• Last Update Posted: June 11, 2014
• Sponsor: Al-Azhar University
• Collaborators: Cairo University; Ain Shams University; Affiliated Hospital to Academy of Military Medical Sciences; Wake Forest University Health Sciences
• Information provided by (Responsible Party): Sayed Bakry, Al-Azhar University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fecal Incontinence	Procedure: Stem Cells Injection Technique; Procedure: Stem Cell Isolation	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
• Study Start Date: October 2013
• Estimated Primary Completion Date: September 2016
• Estimated Study Completion Date: December 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Main outcome measures [ Time Frame: 24 Weeks ]
   Incontinence Score

Secondary Outcome Measures :

1. Assessment of Clinical Parameters [ Time Frame: 24 Weeks ]

   This Including:

   Clinical Assessment. Continence score.

2. Clinical Assessment [ Time Frame: 12 Weeks ]
   Maximum dry interval per day will be measured after injection at day 1, 30 and 90.
3. Clinical Assessment [ Time Frame: 24 Weeks ]
   MRI pelvic floor muscles study will be done after 90 days post injection.
4. Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study) [ Time Frame: 48 Weeks ]
   EMG study will be done after 90, 180 days post injection.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Refaat Ibrahiem El-Badawy; +201001567863

Locations

Egypt

Pediatric Surgery Outpatients Clinics - Al Hussien Hospital; Recruiting

Nasr City, Cairo, Egypt

Contact: Contact: Abdel-Wahab El-Okby, MD +201001478100

Sub-Investigator: Refaat Ibrahiem El-Badawy, MD

Sponsors and Collaborators

Al-Azhar University

Cairo University

Ain Shams University

Affiliated Hospital to Academy of Military Medical Sciences

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Abdel-Wahab El-Okby, MD; Al-Azhar University
• Study Chair: Naglaa Ali Gadallah, MD; Ain Shams University
• Study Director: Sayed Bakry, PhD; Al-Azhar University
• Study Chair: 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

More Information

• Responsible Party: Sayed Bakry, Associate Professor - Consultant of Isolation and Culturing of Stem Cells, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT02161003 History of Changes
• Other Study ID Numbers: Azhar52980070; Azhar52980070 ( Other Grant/Funding Number: Al Azhar University )
• First Posted: June 11, 2014
• Last Update Posted: June 11, 2014
• Last Verified: June 2014

Keywords provided by Sayed Bakry, Al-Azhar University:

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

Additional relevant MeSH terms:

Fecal Incontinence; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases