Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
试验速览
- 阶段
- 2 期
- 发起方
- Cellerix
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
研究概览
简要总结
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.
详细描述
Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.
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
- 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
- •Patients of both sexes older than 18 years of age.
- •Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:
- •No palpation of the fistula tract beneath the perianal skin.
- •A tract that is parallel to the rectum on exploration with a stylet.
- •Associated faecal incontinence.
- •Risk factors of anal incontinence.
- •At least one previous operation for a fistulous disorder.
- •Suprasphincteric trajectories
- •Rectovaginal fistula
- •Prior diagnosis of Crohn's disease.
- •Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.
- •Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.
排除标准
- •Patients that are extremely thin who should not be subjected to liposuction.
- •Known allergy to local anaesthetics or to bovine proteins
- •History of neoplasia in the past 5 years.
- •Patients with a diagnosis of active Tuberculosis at the moment of inclusion.
- •Patients with prior positive markers for any of the following pathogens: Hepatitis B and C, HIV-1 or HIV-
- •Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
- •Patients that have participated in another study in the 30 days prior to this one or that have planned to participate simultaneously in another study.
- •Patients that have not given their informed consent to participate in this study.
- •Psychiatric disorder or other factors that in the judgement of the investigator could complicate the participation of the patient in the study.
- •Breast feeding, gestation or intention to become pregnant up to 6 months after finalising their participation in the study, or that are not using adequate methods of contraception during the same period.
结局指标
主要结局
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
次要结局
- No fistula recurrence after 1 year follow-up