Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
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|ClinicalTrials.gov Identifier: NCT02161003|
Recruitment Status : Unknown
Verified June 2014 by Sayed Bakry, Al-Azhar University.
Recruitment status was: Recruiting
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Procedure: Stem Cells Injection Technique Procedure: Stem Cell Isolation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Main outcome measures [ Time Frame: 24 Weeks ]Incontinence Score
- Assessment of Clinical Parameters [ Time Frame: 24 Weeks ]
Clinical Assessment. Continence score.
- Clinical Assessment [ Time Frame: 12 Weeks ]Maximum dry interval per day will be measured after injection at day 1, 30 and 90.
- Clinical Assessment [ Time Frame: 24 Weeks ]MRI pelvic floor muscles study will be done after 90 days post injection.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161003
|Contact: Refaat Ibrahiem El-Badawy||+201001567863|
|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|
|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|