Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula

June 23, 2005 updated by: Cellerix

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Tres Cantos, Madrid, Spain, 28760
        • Cellerix Sl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)

Secondary Outcome Measures

Outcome Measure
No fistula recurrence after 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellerix

Investigators

  • Principal Investigator: Damian Garcia-Olmo, Prof., Cellerix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

June 22, 2005

First Submitted That Met QC Criteria

June 22, 2005

First Posted (Estimate)

June 23, 2005

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX401/TCFIS
  • Nr. 04-0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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