Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
This trial is active, not recruiting.
|Treatment||non-surgical autologous implant of ascs|
|Start date||October 2004|
|End date||July 2006|
|Trial size||50 participants|
|Trial identifier||NCT00115466, GX401/TCFIS, Nr. 04-0211|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
No fistula recurrence after 1 year follow-up
Male or female participants at least 18 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
|Official title||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|
|Principal investigator||Damian Garcia-Olmo, Prof.|
|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.|
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