Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
- Conditions
- Anal Fistula
- Registration Number
- NCT00115466
- Lead Sponsor
- Cellerix
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
-
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.
- 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-2.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
- Secondary Outcome Measures
Name Time Method No fistula recurrence after 1 year follow-up
Trial Locations
- Locations (1)
Cellerix Sl
🇪🇸Tres Cantos, Madrid, Spain