Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- other: Placebo
- biological: Iltamiocel
Eligibility
Inclusion Criteria:
- Female patient has primary symptoms of SUI, as confirmed by patient medical history
and clinical symptoms, including a focused incontinence evaluation.
Exclusion Criteria:
- Patient has symptoms of pure 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, etc.)
- Patient has more than 2 episode of awakening to void during normal sleeping hours.
- Patient cannot be maintained on a stable dose and/or frequency of medication
(including diuretics) known to affect lower urinary tract function, including but not
limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
for at least 2 weeks prior to screening or is likely to change during the course of
the study.
- Patient is pregnant, lactating, or plans to become pregnant during the course of the
study.
- Patient refuses to provide written informed consent.
- Patient is not at least 18 years of age.
- Patient is not available for the follow-up evaluations as required by the protocol.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Eric Sokol, MD
650-725-5986
I'm interested
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.