NCT02292628已完成1 期
Study Phase I/II, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Number of Serious Adverse Events
研究概览
简要总结
This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.
详细描述
In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in the age group of 18-80 yrs.
- •A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
- •Severity of faecal incontinence of 12 or more in the Wexner Score and / or at least six episodes of faecal incontinence for a period of 28 days.
- •Duration of faecal incontinence of at least two years prior to inclusion.
- •Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.
排除标准
- •More of an external sphincter defect and / or at any level of internal anal canal.
- •Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
- •Current anorectal tumors.
- •Current anal fissures.
- •Anorectal stenosis
- •Chronic pelvic or anorectal pain.
- •Pregnant or 6 months postpartum.
- •Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
- •Malignancies in remission for less than a year before the study. An exception to the basocellular carcinoma (BCC) in "remission" for less than a year.
- •Bleeding diathesis or current anticoagulant therapy.
- •Chemotherapy during the 6 months preceding the study.
- •Previous radiation with evidence of radiation injury in the treated area.
- •Participation in any other clinical study during the 3 months preceding the pre-study visit.
- •Patients with other serious disorders.
- •Patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.
研究组 & 干预措施
Mesenchymal stem cells
Experimental
Autologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells.
干预措施: Infusion of mesenchymal stem cells from adipose tissue (Drug)
Ringer lactate solution
Placebo Comparator
Ringer lactate solution
干预措施: Infusion of placebo (Other)
结局指标
主要结局
Number of Serious Adverse Events
时间窗: 12 months
次要结局
- Changes in the faecal incontinence diary(12 months)
- Jorge-Wexner Score(12 months)
- Anorectal manometry(12 months)
- Faecal Incontinence Quality of Life(12 months)
研究者
研究点 (4)
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