CompletedPhase 1

Autologous Muscle Derived Cells for Underactive Bladder

United States23 participantsStarted 2016-11-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Number of Participants With Study-related Adverse Events at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT02463448

SponsorJason Gilleran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2021-09-18

View on ClinicalTrials.gov More Urinary Retention trials