Autologous Cell Therapy for Female Stress Urinary Incontinence

Cook Group

Status and phase: Completed; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Biological: Autologous Muscle Derived Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008943

09-013

Details and patient eligibility

About

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SUI with normal detrusor activity confirmed with urodynamics
• Bladder capacity >200 ml
• Incontinence has not shown any improvement for at least -6 months
• Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion criteria

• Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
• Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
• Uncontrolled diabetes
• Pregnant, lactating, or plans to become pregnant during course of the study
• Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
• Current or acute conditions involving cystitis or urethritis
• Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Autologous Muscle Derived Cells