Autologous Cell Therapy for Female Stress Urinary Incontinence

Cook MyoSite16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Autologous Muscle Derived CellsBIOLOGICAL

Urethral injection of autologous muscle-derived cells

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Foothills Medical Centre

Calgary, Alberta, Canada

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, approximately 6 weeks

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

Time frame: 30 days

Number of Participants That Experienced AMDC Product-related Events

If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product. No adverse events reported during the study were adjudicated as AMDC product-related.

Time frame: 12 months

Data from ClinicalTrials.gov

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