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

NCT ID: NCT02161003

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stem Cells Injection Technique

Intervention Type: 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 Cell Isolation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: collaborator

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Bakry

Associate Professor - Consultant of Isolation and Culturing of Stem Cells

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdel-Wahab El-Okby, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Naglaa Ali Gadallah, MD

Role: STUDY_CHAIR

Ain Shams University

Sayed Bakry, PhD

Role: STUDY_DIRECTOR

Al-Azhar University

Refaat El-Badawy, MD

Role: STUDY_CHAIR

Al-Azhar University

Hala Gabr, MD

Role: STUDY_CHAIR

Cairo University

Wael Wael Abu El Khier, MD

Role: STUDY_CHAIR

Military Academy

Anthony Atala, MD

Role: STUDY_CHAIR

Director of the Wake Forest Institute for Regenerative Medicine

Mostafa Elbahrawy, MSc

Role: STUDY_CHAIR

Al-Azhar University

Locations

Pediatric Surgery Outpatients Clinics - Al Hussien Hospital

Madīnat an Naşr, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Refaat Ibrahiem El-Badawy

Role: CONTACT

+201001567863

Facility Contacts

Contact: Abdel-Wahab El-Okby, MD

Role: primary

+201001478100

Other Identifiers

Azhar52980070

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Azhar52980070

Identifier Type: -

Identifier Source: org_study_id