Clinical trial NCT02161003: Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
Official title: Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Posterior Sagittal Ano-rectoplasty
Mesenchymal Stem Cell
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Ain Shams University
name: Affiliated Hospital to Academy of Military Medical Sciences
name: Wake Forest University Health Sciences
First posted: 2014-06-11
Enrollment: 50
Sex: MALE
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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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.

Primary outcomes:
measure: Main outcome measures
timeFrame: 24 Weeks
Secondary outcomes:
measure: Assessment of Clinical Parameters
timeFrame: 24 Weeks
measure: Clinical Assessment
timeFrame: 12 Weeks
measure: Clinical Assessment
timeFrame: 24 Weeks
measure: Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Nasr City
country: Egypt
facility: Pediatric Surgery Outpatients Clinics - Al Hussien Hospital
state: Cairo
Study officials:
affiliation: Al-Azhar University
name: Abdel-Wahab El-Okby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Naglaa Ali Gadallah, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Sayed Bakry, PhD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Refaat El-Badawy, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hala Gabr, MD
role: STUDY_CHAIR
affiliation: Military Academy
name: Wael Wael Abu El Khier, MD
role: STUDY_CHAIR
affiliation: Director of the Wake Forest Institute for Regenerative Medicine
name: Anthony Atala, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Mostafa Elbahrawy, MSc
role: STUDY_CHAIR
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