Status:
UNKNOWN
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
Lead Sponsor:
Cellerix
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fi...
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 gl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00115466
Start Date
October 1 2004
End Date
July 1 2006
Last Update
June 24 2005
Active Locations (1)
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1
Cellerix Sl
Tres Cantos, Madrid, Spain, 28760