Royan Institute
Tehran, Iran
NCT Number: NCT01963455
This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for the treatment of stress urine incontinency (SUI) in women.
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Notify Me40 year–65 year
Female
Interventional
Phase 1
Tehran, Iran
The investigators will be assessed the 12-month safety and potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 10 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 30×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MDCs transplantation by paraurethral injection .
Other names: MDCs transplantion by paraurethral injection.
Time frame: 1month
Evaluation the 24hours voiding diary reduction by patient questionaire 2h pad test and By clinical measures by cystourethroscopy and urodynamic before , 1, 3,6 and 12 months after MDCs injection.
Time frame: 1 month
Evaluation the enhance incontinence quality of life (I-Qol) by questionnaire form, before injection of MDCs, 1, 3,6 and 12 months after injection.
Royan Institute
Other Gov
The Effect Evaluation of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Urinary Incontinency
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