drugset / Trial / NCT02334878

Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence

NCT02334878

Phase 3 Completed 50 enrolled Ain Shams Maternity Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are undifferentiated cells which can undergo self-renewal \& differentiation into other cell types like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, \& then re-injected periurethrally. Effectiveness will be compared to that of the surgical treatment (tension-free vaginal tape).

Timeline

Start
2015-10-01
Primary completion
2016-10-30
Completion
2016-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject mesenchymal stem cells Cell therapy 2e+07 cells Other
Subject mesenchymal stem cells Cell therapy 3e+07 cells Other