Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

08-006

This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.

2008-10-09

2011-11-02

2011-11-02

Completed

Early phase I

66

Inclusion Criteria: * Patient has SUI with normal detrusor activity confirmed with urodynamics * Patient has bladder capacity \>200 mL * Patient's incontinence has not shown any improvement for at least -6 months * Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy) Exclusion Criteria: * Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability * Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis) * Patient has uncontrolled diabetes * Patient is pregnant, lactating, or plans to become pregnant during the course of the study * Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment * Patient has current or acute conditions involving cystitis or urethritis * Patient is scheduled to receive radiation treatment to the vicinity * Patients with a history of radiation treatment to the urethra or adjacent structures

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

2023-09-08