Autologous Muscle Derived Cells for Underactive Bladder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants With Study-related Adverse Events at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Number of Participants With Study-related Adverse Events at 6 Months
时间窗: 6 months
Safety of Autologous Muscle Derived Cells in the treatment of underactive bladder as measured by occurrences of study-related adverse events (AEs) reported by 6 months after enrollment. Number of reports of each adverse event is listed for events determined to be definitely or possibly related to study activities.
次要结局
- The Change in Number of Independent Voiding Occurrences Per Day on the 3-day Bladder Diary From Baseline at 12 Months.(12 months)
- 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.(12 months)
- 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.(12 months)
- Number of Participants With Study-related Adverse Events Between 6 and 12 Months(Between 6 and 12 months)
- Change in Incontinence Questionnaire (ICIQ) Long Form Score From Baseline at 12 Months.(12 months)
- Change in Underactive Bladder Questionnaire (UABQ) Score From Baseline at 12 Months(12 months)
- 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.(12 months)
- 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.(12 months)
- Number of Participants With Improvement in Underactive Bladder Symptoms at 12 Months.(12 months)
研究者
Jason Gilleran
Principal Investigator
William Beaumont Hospitals