1340 AUTOLOGOUS MUSCLE DERIVED CELL THERAPY FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE: A MULTI-CENTER EXPERIENCE

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence—Evaluation & Therapy1 Apr 20111340 AUTOLOGOUS MUSCLE DERIVED CELL THERAPY FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE: A MULTI-CENTER EXPERIENCE Kenneth Peters, Melissa Kaufman, Roger Dmochowski, Lesley Carr, Sender Herschorn, Melissa Fischer, Larry Sirls, Pradeep Nagaraju, Daniel Biller, Renee Ward, and Michael Chancellor Kenneth PetersKenneth Peters Royal Oak, MI More articles by this author , Melissa KaufmanMelissa Kaufman Nashville, TN More articles by this author , Roger DmochowskiRoger Dmochowski Nashville, TN More articles by this author , Lesley CarrLesley Carr Toronto, Canada More articles by this author , Sender HerschornSender Herschorn Toronto, Canada More articles by this author , Melissa FischerMelissa Fischer Royal Oak, MI More articles by this author , Larry SirlsLarry Sirls Royal Oak, MI More articles by this author , Pradeep NagarajuPradeep Nagaraju Royal Oak, MI More articles by this author , Daniel BillerDaniel Biller Nashville, TN More articles by this author , Renee WardRenee Ward Nashville, TN More articles by this author , and Michael ChancellorMichael Chancellor Royal Oak, MI More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1161AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Autologous derived cells have been investigated for effectiveness for a variety of indications. Cook MyoSite Autologous Muscle Derived Cells (CMI-AMDC) have been proposed as a potential therapy for stress urinary incontinence (SUI) in women. This is a preliminary report of a prospective, dose-escalating study designed to evaluate the safety and potential effectiveness of 4 different doses of CMI-AMDC to treat SUI. METHODS All patients were women aged 18 and older, had SUI symptoms for a minimum of 6 months, and had failed a prior treatment for their SUI condition. CMI-AMDC were harvested from each patient via a biopsy of the lateral thigh muscle followed by cell isolation and subsequent cell proliferation in culture. Cells were then injected into the donor patient's urinary sphincter. Dose escalation was as follows: 10, 50, 100, and 200 million cells. All patients were evaluated at baseline, 1, 3, 6, and 12 months. Outcome measures included a 3-day diary of incontinence episodes, 24-hour pad weight, and quality of life scores (e.g., UDI-6, IIQ-7). RESULTS Sixty-four women received an injection of CMI-AMDC in this study, with 16 receiving 10 million cells, 16 receiving 50 million cells, 24 receiving 100 million cells, and 8 receiving 200 million cells. The numbers of patients who have completed the 6 month follow-up to date include 16 for the 10 million dose, 15 for the 50 million dose, 6 for the 100 million dose, and 0 for the 200 million dose. There have been no significant treatment-related adverse events associated with the use of CMI-AMDC. Compared to baseline, at 6 months post-treatment the average number of total stress leaks over the 3-day diary period decreased from 10 to 5 for the 10 million dose, 9 to 5 for the 50 million dose, and 10 to 2 for the 100 million dose. Average pad weight decreased from baseline to 6 months in all groups: 24.2 g to 13.7 g with 10 million cells, 33.5 g to 23.4 g with 50 million cells, and 45.3 g to 10.6 g with 100 million cells. The average UDI-6 score improved from baseline to 6 months in all test groups: 60 to 38 for the 10 million dose, 56 to 25 for the 50 million dose, and 47 to 42 for the 100 million dose. The average IIQ-7 score also improved from baseline to 6 months in all groups: 40 to 29 with 10 million cells, 39 to 14 with 50 million cells, and 38 to 17 with 100 million cells. CONCLUSIONS CMI-AMDC appears to be a safe and effective treatment for SUI in women. Results suggest that a higher dose of injected cells is associated with greater improvement in incontinence symptoms. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byWein A (2012) Re: The Clinical Relevance of Cell-Based Therapy for the Treatment of Stress Urinary IncontinenceJournal of Urology, VOL. 188, NO. 6, (2303-2305), Online publication date: 1-Dec-2012. Volume 185Issue 4SApril 2011Page: e535-e536 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kenneth Peters Royal Oak, MI More articles by this author Melissa Kaufman Nashville, TN More articles by this author Roger Dmochowski Nashville, TN More articles by this author Lesley Carr Toronto, Canada More articles by this author Sender Herschorn Toronto, Canada More articles by this author Melissa Fischer Royal Oak, MI More articles by this author Larry Sirls Royal Oak, MI More articles by this author Pradeep Nagaraju Royal Oak, MI More articles by this author Daniel Biller Nashville, TN More articles by this author Renee Ward Nashville, TN More articles by this author Michael Chancellor Royal Oak, MI More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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