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This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle derived stem cell | Experimental | Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paraurethral injection | Biological | Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24hr voiding diary reduction | Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| incontinence quality of life (I-Qol) | Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form. | 1month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute | Study Director |
| Farzaneh Sharifiaghdas, MD | Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences | Study Director |
| Farshad Zohrabi, MD | Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Reza Moghadasali, PhD | Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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