Cook MyoSite Incorporated AMDC Female SUI Clinical Study--10-019-02_EU

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence

• IRAS ID

  91853

• Contact name

  Waleed Al-Singary

• Sponsor organisation

  Cook MyoSite, Incorporated

• Eudract number

  2011-003599-35

• Clinicaltrials.gov Identifier

  NCT01382602

• Research summary

  The purpose of this study is to evaluate the safety and potential Effectiveness of a new medical procedure for women with Stress Urinary Incontinence (SUI), the involuntary leakage of urine on effort or exertion, or on'sneezing or coughing. SUI symptoms can occur for two reasons: 1) loss of support in the pelvic floor or bladder or 2) sphincter muscle function deficiency. Repair of sphincter function may allow for improvement in'sUI symptoms from either cause. The procedure uses Cook MyoSite Incorporated Autologous Muscle Derived Cells (AMDC). AMDC are muscle progenitor cells isolated from a patient's skeletal muscle tissue. The tissue is collected from a muscle biopsy of the patient's thigh, sent to the manufacturer for processing, and the resulting cells are sent back to the physician. The cells are injected into the urethral sphincter of the same patient. This study is designed to have both a treatment group (injection with cells) and a placebo group (injection without cells). Both groups will receive either one or two treatments, and are randomized into four total groups: 1) treatment with cells one time, 2) treatment with cells two times, 3) treatment with placebo one time, and 4) treatment with placebo two times. The study is double-blinded, meaning that the physician and patient do not know if the treatment is cells or placebo. Patient follow-up occurs at 1, 3, 6, 12, and 24 months post-initial injection. Primary study outcomes are number and amount of Stress leaks (as measured by patient diary and pad weights, respectively) and safety at 12 months post-initial injection. patients in the placebo group will have the option of the cell treatment after completing the 12 month follow-up visit. Up to 30 institutions in Canada and Europe will participate in this study, and up to 246 patients will be treated.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/0739

• Date of REC Opinion

  25 Sep 2012

• REC opinion

  Further Information Favourable Opinion