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Cell Therapy in Women's Health for Stress Urinary Incontinence
RBR-29x2prPhase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2018
- Countries
- 1
- Sponsor
- Federal University of São Paulo
- Modality
- Stem Cell Therapies → Cell Therapies
- Conditions
- stress urinary incontinence (SUI)
01
Overview
Phase 2, open-label trial of autologous bone marrow-derived stem cells in stress urinary incontinence (SUI) (3 arms), sponsored by Federal University of São Paulo. Started Jan 2018; status: recruiting.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
CTDM group
Periurethral injection of 10 million autologous skeletal muscle-derived stem cells.
CTMO group
Periurethral injection of 10 million autologous bone marrow-derived stem cells.
CTA group
Periurethral injection of 10 million autologous adipose tissue-derived stem cells.
03
Who it enrols
Only adult women with moderate primary refractory stress urinary incontinence confirmed by stress cough test, urodynamic study, or pad test are eligible.
04
Endpoints
Secondary
Quality of life questionnaire
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