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Safety of 4 Doses of Autologous Muscle Derived Cells for SUI
NCT00847535Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2008
- Primary completion
- Nov 2011
- Countries
- 2
- Sponsor
- Cook MyoSite
- Modality
- Cell Therapies
- Drugs
- AMDC-USR
- Conditions
- stress urinary incontinence (SUI)
01
Overview
Phase 2, open-label trial of AMDC-USR in stress urinary incontinence (SUI) (2 arms), sponsored by Cook MyoSite. Primary endpoints: Number of Participants That Experienced Biopsy Procedure-related Adverse Events, Biopsy Procedure-related Adverse Events and 3 more. Started Oct 2008; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Transurethral dose escalation
Transurethral injection of AMDC at escalating doses
Periurethral dose escalation
Periurethral injection of AMDC at escalating doses
03
Who it enrols
Adult female patients with stress urinary incontinence who have failed prior conservative or surgical treatments, have normal detrusor activity, and bladder capacity >200 mL.
04
Endpoints
Primary
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Biopsy Procedure-related Adverse Events
Number of Participants That Experienced Injection Procedure-related Adverse Events
Injection Procedure-related Adverse Events
Number of Participants That Experienced AMDC Product-related Adverse Events
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