Phase 1
N=23
Autologous Muscle Derived Cells for Underactive Bladder
Urinary Retention · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02463448 ↗Enrolled (actual)
23
Serious AEs
20.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Study-related Adverse Events at 6 Months — 2; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Autologous Muscle Derived Cells (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jason Gilleran
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Study-related Adverse Events at 6 Months |
2; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Study-related Adverse Events Between 6 and 12 Months |
1; 1 | — |
| SECONDARY Number of Participants With Improvement in Underactive Bladder Symptoms at 12 Months. |
0; 3; 9; 5; 0; 0 | — |
| SECONDARY Number of Participants With Improvement in Underactive Bladder Symptoms at 12 Months. |
0; 3; 9; 5; 0; 0 | — |
| SECONDARY Change in Incontinence Questionnaire (ICIQ) Long Form Score From Baseline at 12 Months. |
0.6667; 1.071 | — |
| SECONDARY Change in Underactive Bladder Questionnaire (UABQ) Score From Baseline at 12 Months |
5.7 | — |
| SECONDARY The Change in Number of Independent Voiding Occurrences Per Day on the 3-day Bladder Diary From Baseline at 12 Months. |
-0.665 | — |
| SECONDARY The Change in the Number of Voiding Occurrences Per Day Using a Catheter Recorded on the 3-day Bladder Diary From Baseline at 12 Months. |
-0.2094 | — |
| SECONDARY The Change in the Average Volume Voided Independently Per Day Measured in Milliliters Over the 3 Day Period Recorded on the 3-day Bladder Diary From Baseline at 12 Months. |
-156.66 | — |
| SECONDARY The Change in the Average Volume in Milliliters Voided Per Day Using a Catheter Per Day Over the 3 Day Period Recorded on the 3-day Bladder Diary From Baseline at 12 Months. |
-894.9 | — |
| SECONDARY The Change in the Number of Bladder Leaks Over the 3 Day Period Recorded on the 3-day Bladder Diary From Baseline at 12 Months. |
— | — |
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
- 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
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)
- 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)
Data sourced from ClinicalTrials.gov (NCT02463448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.