Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Proportion of patients with at least one of the complictations derived from the treatment.
研究概览
简要总结
Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.
详细描述
It's a controlled trial, in phase I, proof of concept, safety and preliminary analysis of efficacy. It is planned to make 2 cohorts of patients, one with a single dose of 40 million HC016 and another group with saline solution (control).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 50 years old
- •Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate.
- •The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.
- •Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment
- •Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment
- •Signing of the informed consent form
排除标准
- •Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecological/colorectal surgery
- •Major surgery or serious trauma of the subject in the previous semester
- •Women with mixed urinary incontinence, with predominant symptoms of urgency
- •History of high-pressure detrusor overactivity
- •Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by urethrocystoscopy, urethrocystography and flowmetry).
- •Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years.
- •Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious enough to exclude the patient from the study.
- •Medical or psychiatric illness of any type that, in the opinion of the researcher, may be a reason for exclusion from the study.
- •History of alcohol or other addictive substance abuse in the 6 months prior to inclusion
- •Subject's allergy to anesthetics
研究组 & 干预措施
single dose of 40 million HC016
They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40
干预措施: allogeneic mesenchymal stem cells (Drug)
Saline solution
They will receive a single dose of the saline solution in which the HC016 cells are conditioned, which consists of lactated ringer's, glucosaline, sodium bicarbonate and human albumin. N=20
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with at least one of the complictations derived from the treatment.
时间窗: 7 days
complications derived from treatment will be considered: * Complications during anesthesia. * Complications during treatment administration. * Peri- and postoperative complications. * Adverse effects during follow-up, whether or not associated with the drug
次要结局
- The evaluation of the PAD-test(3 moths and 6 months)
- Flowmetry values(3 months)
- Quality of life SF-12 questionnaire(3 moths and 6 months)
- Quality of life ICQ-SF questionnaire(3 moths and 6 months)