NCT00847535 - An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

66

Conditions

Stress Urinary Incontinence Cell Therapy

Interventions

autologous muscle cell injectionBIOLOGICAL

Injection of autologous muscle cells

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Wm Beaumont Hospital

Royal Oak, Michigan, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Number of Participants That Experienced Biopsy Procedure-related Adverse Events

Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.

Time frame: at biopsy or between biopsy and treatment

Biopsy Procedure-related Adverse Events

Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.

Time frame: at biopsy or between biopsy and treatment

Number of Participants That Experienced Injection Procedure-related Adverse Events

AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.

Time frame: 30 days

Injection Procedure-related Adverse Events

AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.

Time frame: 30 days