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IRCT20160201026316N4 IRCT 2019-07-20 Iran University of Medical Sciences Stem Cell therapy on human Fecal incontinence Results assessment of allogenic implantation of human Adipose drived stem cells in external anal sphincter and fecal incontinence: a phase II clinical trial 2019-08-23 anticipated 30 Complete https://irct.ir/trial/40727 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A permuted block randomization (block size 3) is used to implement the random allocation sequence without stratification for baseline characteristics. An independent physician generate the random allocation sequence by a computer-based program, enrolled participants, and assigned participants to interventions, Blinding description: Four separate researchers prepare the suspensions, carry out the treatment administration, record patients’ data, and data analysis. The patients and the surgeons who perform the surgery, sonographic, and physical examinations are blind to the type of treatment (double blind). To ensure the blinding of the surgeon to the type of treatment, the cell suspension and placebo are both prepare in packages which appeared to be the same. 2 Faecal incontinence. Intervention 1: Intervention group: External anal sphincter muscle repair and 20 milions hADSCs ( suspended in 3 ml Phosphate Buffer Solution) implantation in the external anal sphincter is done. Intervention 2: Control group: External anal sphincter muscle repair without implantation in the external anal sphincter is done. Yes - There is a plan to make this available What will be shared: No available data When: No available data To whom: No available data Conditions: No available data Where to obtain: No available data How to obtain: No available data Comments:
public Arash Sarveazad
Rasoul Akram Hospital, Niayesh street, Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 Arashsarveazad@gmail.com Iran University of Medical Sciences scientific Bahar Mahjoubi
Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 Bahar1167@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Age >25 years Wexner score ≥ 8 Confirmation of external anal sphincter defect with endorectal ultrasonography Patient consent for inclusion 25 years no limit Both Pregnancy and breastfeeding Participating in other trials within the past 30 days History of artificial sphincter Vaginal delivery within the past 6 months Presence of chronic diseases Autoimmune disease R15 Fecal incontinence Treatment - Other Treatment - Surgery Intervention group: External anal sphincter muscle repair and 20 milions hADSCs ( suspended in 3 ml Phosphate Buffer Solution) implantation in the external anal sphincter is done. Control group: External anal sphincter muscle repair without implantation in the external anal sphincter is done. Wexner Score. Timepoint: 2 months after intervention. Method of measurement: Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history). Rate of wound closure. Timepoint: Immediately after surgery to wound closure. Method of measurement: Experienced surgeon view. External anal sphincter action potential record in the defect site. Timepoint: Two months after intervention. Method of measurement: Electromyography. External anal sphincter morphology. Timepoint: Two months after intervention. Method of measurement: Endorectal Sonography. Amount of muscle in the external anal sphincter defect site. Timepoint: Two months after intervention. Method of measurement: Image J software. Iran University of Medical Sciences Approved 2019-07-15 Ethics committee of Iran University of Medical Sciences Rasoul Akram Hospital, Niayesh Street, SattarKhan Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)