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
