Muscle Fiber Fragment Treatment for Urinary 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