An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

Cook Group

Status and phase

Completed

Phase 2

Conditions

Stress Urinary Incontinence

Cell Therapy

Treatments

Biological: autologous muscle cell injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00847535

IND1

08-006

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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