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

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

Interventions

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.

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Ain Shams University

  collaborator OTHER

• Affiliated Hospital to Academy of Military Medical Sciences

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Al-Azhar University

  lead OTHER

Principal Investigators

• Abdel-Wahab El-Okby, MD · Al-Azhar University

• Naglaa Ali Gadallah, MD · Ain Shams University

• Sayed Bakry, PhD · Al-Azhar University

• Refaat El-Badawy, MD · Al-Azhar University

• Hala Gabr, MD · Cairo University

• Wael Wael Abu El Khier, MD · Military Academy

• Anthony Atala, MD · Director of the Wake Forest Institute for Regenerative Medicine

• Mostafa Elbahrawy, MSc · Al-Azhar University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• Egypt

Study Locations