Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair

Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity,
such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary
Sphincter Repair (AMDC-USR) involves a medical procedure in which a participant's own muscle
cells are collected, processed, and then injected into the tissues of the urinary passage.

This is a double-blind randomized study, which means neither the participant, nor the study
doctor will know which treatment group the participant will be in. Participants who are
randomly chosen to receive injection with placebo will have the option to receive an
injection with their cells after completion of the blinded portion of their study
participation (12 months).

Inclusion Criteria:

- Adult female patient 50 to 75 years of age who has primary and moderate-to-severe
symptoms of SUI for at least 6 months, as confirmed by patient medical history and
clinical symptoms, including a focused incontinence evaluation.

- Must be willing and able to comply with the study procedures, be mentally competent
and able to understand all study requirements, and must agree to read and sign the
informed consent form prior to any study-related procedures.

- Must have completed 100% of the screening 3-day diary evening reports.

Exclusion Criteria:

- Patient has symptoms of only urge incontinence as confirmed by basic evaluation of
etiology from a patient medical history, including a focused incontinence history.

- Patient has symptoms of mixed urinary incontinence where urge incontinence is the
predominant factor.

- Patient has had stress urinary incontinence symptoms less than 6 months prior to
signing the informed consent.

- Patient has not previously attempted conservative treatment prior to signing the
informed consent. (Examples of conservative treatment include behavior modifications,
bladder exercises, biofeedback, pelvic floor muscle therapy, etc.)

- Patient BMI ≥ 35.

- Patient routinely has more than 2 episodes of awakening to void during normal sleeping
hours.

- If taking a medication known to affect lower urinary tract function, including but not
limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic
antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective
serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic
blockers, patient cannot be maintained on a stable dose and/or frequency of medication
(including diuretics), cannot be maintained on a stable dose and/or frequency for at
least 2 weeks prior to screening or is likely to change during the course of the
study.

- History of cancer in pelvic organs, ureters, or kidneys.

- Patient is pregnant, lactating, or plans to become pregnant during the course of the
study.