CELLEBRATE Research Study – Women with Stress Urinary Incontinence

STUDY BASICS

Are you a woman age 18 or older? Do you experience involuntary urinary leakage due to physical activities such as coughing, sneezing, laughing, or exercising? If so, you may be eligible to participate in a research study to help find out if an investigational product for women with stress urinary incontinence is safe and effective.

STUDY PURPOSE

Urinary incontinence is the involuntary release of urine. The most common type of urinary incontinence in women is stress incontinence, which is the accidental leakage of urine due to physical activities such as coughing, sneezing, laughing, or exercising. Stress incontinence can be caused by childbirth, weight gain, or other conditions that stretch and weaken the pelvic floor muscles supporting the bladder.

The purpose of this study is to find out if an investigational product is a safe and effective treatment for women with stress urinary incontinence. Treatment with the investigational study product involves a medical procedure in which your own muscle cells are collected, processed, and then injected into the tissues of your urinary passage. It is believed the cells will become part of the tissue where they have been injected. In theory, this may help women have more control over urine storage and urination and may decrease urinary leakage.

COULD THIS STUDY BE RIGHT FOR YOU?

• Females aged 18 and over
• Experience involuntary urine leakage caused by physical activities such as coughing, sneezing, laughing, or exercising
• Prior surgical treatment (for example, a ‘sling’, transvaginal taping, or retropubic suspension) for urinary leakage.

WHAT PARTICIPANTS CAN EXPECT

The clinical study lasts two and a half years and participation includes approximately 8 to 11 office visits and 3 to 5 scheduled phone calls. The study will consist of a screening period, which may last up to 8 weeks to determine eligibility.

Participants will be randomized into one of two study groups––half will receive AMDC-USR (injections with cells) and the other half will receive a placebo (injections that look and feel exactly the same but will have no cells). Randomization, is done by computer.  Neither the volunteers nor the researchers will know what group you are in. If the participant receives the placebo injection, the participant will still have the option of receiving a second injection with their own cells (the AMDC-USR product) after 12 months.

Other tests, assessments, and procedures during the study include the following: a biopsy to collect muscle tissue from the thigh, physical exam, bladder and urinary passage tests, ultrasound, blood draws, urine collection, questionnaires, and patient diary completion.

Participants will be reimbursed $100 for each study visit.