Multicentre, randomized, comparative and Add-on, in two parallel groups to assess the efficacy and safety of autologous mesenchymal stem cells derived from expanded adipose tissue (ASC) for the treatment of complex perianal disease in patients without disease inflammatory bowel disease.

Fundación para la Investigación Biomédica del Hospital Universitario La Paz0 个研究点目标入组 80 人开始时间: 2012年6月12日最近更新: 2018年12月4日

试验速览

暂无简介。

•- Signed informed consent
•- Perianal complex fistula with criptoglandular origin, that means fistula with some of the following circumstances:
•_Some grade of fecal incontinence
•_ Extra-sphincter fistula
•_Supra-sphincter fistula
•_Trans-sphnicter fistula
•_Patients both sexs elder than 18 years old. Good clinical condition, according to the patient medical notes and physical examination.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patient diagnosed with intestinal inflammatory disease.
•-Patients with abscess, unless a complete cleaning of the zone with drainage of the collections is done and the absence of abscess and other collections majors than 2 cm of maximum diameter is confirmed before initiating the treatment.
•-Antecedents of alcohol or other addictive substances abuse in the 6 months previous to the inclusion.
•-Malignant neoplasia, unless it is a skin basocelular or epidermoide carcinoma or antecedents of malignant tumors, unless they have been in remission phase during the 5 previous years.
•-Cardiopulmonary disease that, according to the investigator, is unstable or revista is sufficiently serious to discard the patient from the study.
•-Medical or psychiatric disease of any type that, according to the investigator, can suppose a reason for exclusion from the study.
•-Subjects with congenital or acquired immunodeficiencies. Hepatitis B and/or C or tuberculosis diagnosed during the inclusion
•-Greater surgery or serious traumatism of the patient in the previous semester.
•-Pregnant or breastfeeding women.
•- Adult women of childbearing age not using effective contraception during the trial.
•-Administration of any other drug in investigation at present or any time during the three months prior the recruitment for this trial.

发起方

Fundación para la Investigación Biomédica del Hospital Universitario La Paz