This Clinical Research study is being conducted to evaluate the safety and effectiveness of an investigational cellular product in women with Stress Urinary Incontinence.
Study participants will undergo a muscle biopsy; cells from each participant’s biopsy will be processed for re-injection as investigational product into the participant’s urethral sphincter with the intent to determine if bladder control improves.
Study participants will be randomly assigned to study treatment with the investigational product or a placebo by an electronic, automated system. Two out of every three participants will receive an injection of their own cells (the remaining participants will receive a placebo injection containing no cells). Symptoms and other measurements of SUI in each group will be compared over the course of the study. Patients receiving the placebo injection will have the option to have treatment with the investigational product using their own cells following the 12 month visit.
Participants in the study will be also asked to return for approximately 6 clinic visits over 2 years to assess their quality of life and have other tests performed (blood and urine tests, for example). Participants will also be asked to maintain an electronic diary (similar to a smart phone) between visits to help monitor SUI episodes.
Find out if you may qualify for participation in this investigational study.