Autologous Muscle Derived Cells for Female Urinary Sphincter Repair


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Trial ID: NCT01893138


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.

Official Title

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Stanford Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD

Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology


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

   - 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.


other: Placebo

biological: Iltamiocel


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eric Sokol, MD