Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of SUI episode frequency
研究概览
简要总结
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.
详细描述
Stress urinary incontinence (SUI) is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other activities that increase pressure on the abdomen and, subsequently, the bladder.
The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.
The study will be conducted as a self-controlled case series (SCCS) with each patient serving as their own comparators. Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy approximately 12 weeks later, an injection of MPCCOLs up to 5 weeks later, and follow-up visits at 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.
All patients will be treated with one of two doses of MPCCOL, assigned according to the study's randomization method.
Half of the participating patients will receive the tissue engineered product (TEP) dose that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. All study participants will be monitored via medical examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Neither patient nor sponsor will know which patient gets which dose
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Predominant clinical diagnosis of SUI
- •Stress incontinence ≥ grade I for at least 6 months
- •Patient has at least once been treated with, and failed prior conservative treatments
- •Patient had no improvement of SUI symptoms for at least 6 months before enrollment
- •Patients with a certain amount of leaks or /and a predefined pad weight at screening
- •Candidate for a surgical treatment
- •Negative blood test: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab and Syphilis
- •Negative laboratory or blood test, and medical examination to eliminate risk of sexually transmitted diseases (STD) per investigators' discretion
- •Competent to comprehend, sign, and date informed consent form before any study-specific procedure is performed
- •Able to communicate well with the Investigator, and to understand and comply with the requirements of the study including answering the required questionnaires
排除标准
- •History of anti-incontinence surgery or prolapse surgery.
- •Diagnosed Hypermobile Urethra
- •Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
- •Clinically significant cystocele or rectocele
- •Ureteric bladder, urethral or rectal fistula
- •Uncorrected congenital abnormality leading to urinary incontinence
- •Interstitial cystitis
- •Urinary urgency that results in leakage (as a predominant symptom)
- •Adult enuresis
- •Urodynamically proven detrusor instability or detrusor sphincter dyssynergia (DSD)
- •Sensory urgency defined as first sensation of bladder fill (urge to void) of <100 ml
- •No sensation at any time during the simple filling cystometry procedure
- •Known urethral Stenosis (ureterocystoscopy) or urethral diverticulum
- •History of cancer (< 5 year of remission) or history of pelvic radiotherapy
- •Immunosuppressed patients
- •Women who are pregnant or become pregnant during the course of the study, breast feeding or <12 months postpartum
- •Untreated symptomatic urinary tract infection
- •Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
- •Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
- •Known allergy/intolerance to at least one of the active ingredients or excipients of the investigational products
- •Known allergy/intolerance to Penicillin or Streptomycin.
- •Known genetically determined or acquired muscular disease, known neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism, Creutzfeldt-Jakob disease).
- •Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study.
- •Chronic use of defined drugs and not stopped prior to inclusion into or including the study. Selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
- •Have any clinically significant coexisting condition or symptoms that, in the opinion of the investigator, would put the safety of the participant at risk.
- •Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
- •Medication known to affect lower urinary tract function.
- •Patients having any electrical device inside their body (such as a cochlear implant, TENS stimulator (for pain), vagal nerve stimulator, brain stimulator, gastric pacemaker, bladder stimulator, or an implanted mechanical pump (such an insulin pump or pain pump).
- •Patients having a cardiac pacemaker or defibrillator implant.
- •Patients with Starr-Edwards artificial heart valve.
- •Patients that suffer from claustrophobia.
研究组 & 干预措施
Low dose
Already human tested low dose from phase I study
干预措施: autologous muscle precursor cells (Biological)
High dose
First in human dose used for efficacy reasons during phase II
干预措施: autologous muscle precursor cells (Biological)
结局指标
主要结局
Change of SUI episode frequency
时间窗: 8-9 months
Assessment in episode change measured using a bladder diary, from baseline to 6 months after injection.
次要结局
- Incidence of (S)AEs(6-8 months)
- Change in 24 hour pad weight(8-9 months)
- Number of patients with any clinical significant findings(8-9 months)