Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence

Inclusion Criteria: * Female outpatients, predominant clinical diagnosis of SUI * Have discrete episodes of incontinence (that is, are dry between episodes and not continuously leaking urine, synchronous with increased intra-abdominal pressure from coughing, sneezing, exercising, etc.) * Have a positive Fixed Bladder Volume Cough Stress Test (CST) result; and post void residual volume of \<50 ml * Report normal urinary diurnal (≤8/day) and nocturnal (≤2/night) frequency per micturition history * Have had symptoms of SUI for a minimum of 3 months prior to study entry * Can independently use toilet without difficulty * If patients regularly use laxatives, stool softeners, or stool-bulking agents (for example, fibre supplements), the use of these products should remain constant during participation in the study. * Competent to comprehend, sign, and date an Ethics Committee approved informed consent form before any study-specific procedure is performed. * Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrolment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[IUD\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study. Exclusion Criteria: * Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract: * Greater than Stage I Anterior (cystocoele), Apical (uteri), or Posterior (rectocoele) Compartment Prolepses as per the POP-Q) * Ureteric bladder, urethral or rectal fistula * Uncorrected congenital abnormality leading to urinary incontinence * Interstitial cystitis * Urinary urgency that results in leakage (as a predominant symptom) * Adult enuresis * Urodynamically proven: * detrusor instability * sensory urgency defined as first sensation of bladder fill (urge to void) of \<100 ml; bladder capacity of \<300 ml * voiding difficulty * Have no sensation at any time during the simple filling cystometry procedure * Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment * Have a symptomatic urinary tract infection (UTI); or have a history of four or more urinary tract infections in the preceding year. * Have prolonged menstruation (\>14 days per month). * Have history of (or currently have) urogenital cancer. * Suffer from severe constipation defined as less than one bowel movement per week * Are pregnant, \<12 months postpartum or are lactating * Have had any major inpatient surgery within 3 months prior to study entry * Known infection with human immunodeficiency virus (HIV) * Known active infection with Hepatitis B virus, Hepatitis C virus or Lues. * Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results. * Have had any anti-incontinence or prolapse surgery, including the following: * Anterior Repair * Needle Suspension such as Raz; Pereyra; Stamey; Gittes; and Muzsnai procedures * Retropubic Procedures: such as Marshall, Marchetti \& Krantz; and Burch procedures * Sling Procedure * Collagen Injections * Artificial Sphincter. * Use any of the following: * Any anti-incontinence device (for example, Reliance, Minigard, or FemAssist) including tampons used to prevent incontinence during participation in the study * Vaginal pessaries for prolapse or incontinence * Any nonpharmacologic intervention for incontinence or prolapse (for example, electro stimulation, vaginal cones, or any such device) within the 3 months prior to study entry. * Current use of any of the following drugs: antidepressants, duloxetine, monoamine oxidase inhibitors or other, clonidine, alpha-methyl-DOPA, beta-blockers, guanethidine, reserpine, pentosan polysulfate, or alpha-receptor antagonists/agonists (chronic use). * Current use of any medications for the treatment of urinary incontinence. * Are on a medication regimen including estrogens, anti-estrogens, or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks, or is anticipated to change during the course of the study. * ≤ 30 days since receiving an investigational medicinal product or device in another clinical trial. Current enrollment in another clinical trial is not permitted. * Allergy/ intolerance of at least one of the active ingredients or excipients of the investigational products, e.g. bovine protein, gentamycin * Have any abuse disorder within the 5 years prior to study entry; e.g. patients who report regular consumption of \>21 alcoholic drinks per week (an average of 3 drinks per day)