Autologous Muscle Derived Cells for Underactive Bladder
Condition: Urinary Retention; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Retention; Urinary Bladder, Underactive
Intervention: Autologous Muscle Derived Cells
Intervention description: A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Underactive Bladder

Summary:

      This is a prospective, open-label, Phase 1, single center study evaluating the safety and
      efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.
    

Eligibility criteria:

        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)