NCT01963455

Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

The Effect Evaluation of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Urinary Incontinency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for the treatment of stress urine incontinency (SUI) in women.

Detailed description

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.

Conditions

• Stress Incontinency

Interventions

Type	Name	Description
BIOLOGICAL	paraurethral injection of MDCs	MDCs transplantation by paraurethral injection .

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-10-16
• Last updated: 2015-05-06

Locations

1 site across 1 country: Iran