Autologous Muscle Derived Cells for Underactive Bladder

Jason Gilleran

Status and phase: Completed; Phase 1

Conditions: Urinary Retention; Urinary Incontinence

Treatments: Biological: Autologous Muscle Derived Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02463448

2015-134

Details and patient eligibility

About

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.

Full description

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 12 months. The follow-up assessments at 12 months will include questionnaires, urine and blood testing, specialized bladder function testing and visualizing the inside of the bladder with a lighted instrument.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Autologous Muscle Derived Cells

Experimental group

Description:

Autologous Muscle Derived Cells are obtained by needle biopsy from the subject's own thigh muscle. These cells are sent to a special lab for growth and processing. When ready the cells are sent to the treatment location for injection into the bladder wall.

Treatment:

Biological: Autologous Muscle Derived Cells