Autologous Muscle Derived Cells for Underactive Bladder

Completed · Phase 1

Conditions studied: Urinary Retention, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT02463448

Run by

Jason Gilleran

People needed

23

Starts

2016-11-16

Expected to finish

2020-11-01

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, at least 18 years of age
• History of Underactive Bladder (UAB) for at least 6 months documented in the medical record
• Recurring UAB symptoms
• Subjects unresponsive to relief symptoms of UAB with previous use of medications and/or other treatments
• Voiding difficulty (complains of difficulty emptying the bladder)
• Post void residual greater than or equal to 150 mL
• Total UAB Questionnaire Score greater than or equal to 3
• Females of child-bearing potential agree to use a reliable form of birth control for the entire study duration
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires

You may not qualify if…

• Pregnant, plans to become pregnant or lactating
• History of bleeding diathesis, uncorrectable coagulopathy, or would refuse a blood transfusion
• Currently on anticoagulant therapy
• Obvious neurological impairment
• Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, ampicillin, and/or lidocaine that medically warrants exclusion as determined by the physician
• 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
• Has been treated with an investigational device, drug, or procedure for UAB within the last 6 months.
• 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)
• History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
• History of radiation therapy to the bladder
• 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
• Abnormal renal function
• An active urinary tract infection as evidenced by positive urine culture
• 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
• Requires concomitant use of or treatment with immunosuppressive agents
• Pelvic organ prolapse beyond the introitus (e.g., cystocele, rectocele)
• Abnormal bladder capacity (i.e., less than 100 mL)

Where it is running

• Beaumont Health — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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