Autologous Muscle Derived Cells for Underactive Bladder

Subject that meet inclusion and exclusion criteria will be consented and enrolled in this
study. Initial screening includes blood and urine testing, questionnaires, physical
examination, specialized bladder function testing and review of medical history. At the next
visit a small sample of each subject's own thigh muscle is obtained by needle biopsy. This
cell biopsy is sent to a specialized lab for growth and processing. Approximately ten weeks
later the frozen cells will be sent back to the treatment site for thawing, diluting and
injection under lighted instrumentation into the subject's bladder wall. The subject will be
followed for 6 months and at that time may be eligible for a second injection of cells. The
study doctor will determine if the second injection may be beneficial to the subject. All
subjects will be followed for up to 24 months. The long term follow-up assessments at 12, 18
and 24 months will include questionnaires, urine and blood testing, specialized bladder
function testing and visualizing the inside of the bladder with a lighted instrument (at the
12 month assessment only).

Inclusion Criteria:

1. Males and females, at least 18 years of age

2. History of Underactive Bladder (UAB) for at least 6 months documented in the medical
record

3. Recurring UAB symptoms

4. Subjects unresponsive to relief symptoms of UAB with previous use of medications
and/or other treatments

5. Voiding difficulty (complains of difficulty emptying the bladder)

6. Post void residual greater than or equal to 150 mL

7. Total UAB Questionnaire Score greater than or equal to 3

8. Females of child-bearing potential agree to use a reliable form of birth control for
the entire study duration

9. Willing and capable of understanding and complying with all requirements of the
protocol, including proper completion of the voiding diaries and self-administered
questionnaires

Exclusion Criteria:

1. Pregnant, plans to become pregnant or lactating

2. History of bleeding diathesis, uncorrectable coagulopathy, or would refuse a blood
transfusion

3. Currently on anticoagulant therapy

4. Obvious neurological impairment

5. Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate,
ampicillin, and/or lidocaine that medically warrants exclusion as determined by the
physician

6. Simultaneously participating in another investigational drug or device study or use of
any investigational drug(s) or therapeutic device(s) within 3 months preceding
enrollment

7. Has been treated with an investigational device, drug, or procedure for UAB within the
last 6 months.

8. Medical condition or disorder that may limit life expectancy or that may cause
protocol deviations (e.g. unable to perform self-evaluations and/or accurately report
medical history, urinary symptoms, and/or data)

9. History of cancer in pelvic organs, ureters, or kidneys or any cancer that has
undergone treatment within the past 12 months

10. Compromised immune system due to disease state, chronic corticosteroid use, or other
immunosuppressive therapy

11. History of radiation therapy to the bladder

12. Tests positive for Hepatitis B (Hepatitis B Surface Antigen), and Anti-Hepatitis B
Core Total Antibody, Hepatitis C (Anti-Hepatitis C virus enzyme immunoassay, Human
Immunodeficiency Virus (HIV Type I and 2 Antibodies), and/or Syphilis

13. Abnormal renal function

14. An active urinary tract infection as evidenced by positive urine culture

15. Taking medication(s) that affect urination (e.g. medically necessary, stable drugs)
such as prescription drugs, over-the-counter drugs, or dietary supplements, including
herbal supplements and those taken with teas

16. Requires concomitant use of or treatment with immunosuppressive agents

17. Pelvic organ prolapse beyond the introitus (e.g., cystocele, rectocele)

18. Abnormal bladder capacity (i.e., less than 100 mL)