Muscle Fiber Fragment Treatment for Urinary Incontinence

Inclusion Criteria: * Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator * Patients between the ages of 18 and 75 years * Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions. * Patients with cystometric capacity of bladder \> 100 ml * Patients with normal renal function * Patients with a history of primary incontinence Exclusion Criteria: * Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder * Patients with an active urinary tract infection as evidenced by positive urine culture * Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas * Patients requiring concomitant use of or treatment with immunosuppressive agents * Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study * Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy) * Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study * Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study * Patients with urinary incontinence other than the categories being investigated * Patients with significant (\>grade 2) pelvic organ prolapse * Patients with vaginal prolapse beyond introitus * Patients with neurological disorders * Patients with abnormal bladder capacity (i.e., less than 100 cc) * Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment