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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Cellerix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cellerix
ClinicalTrials.gov Identifier:
NCT00115466
First received: June 22, 2005
Last updated: June 23, 2005
Last verified: June 2005
  Purpose

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.


Condition Intervention Phase
Anal Fistula
Procedure: Non-surgical autologous implant of ASCs
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cellerix:

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

Secondary Outcome Measures:
  • No fistula recurrence after 1 year follow-up

Estimated Enrollment: 50
Study Start Date: October 2004
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115466

Locations
Spain
Cellerix Sl
Tres Cantos, Madrid, Spain, 28760
Sponsors and Collaborators
Cellerix
Investigators
Principal Investigator: Damian Garcia-Olmo, Prof. Cellerix
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00115466     History of Changes
Other Study ID Numbers: GX401/TCFIS, Nr. 04-0211
Study First Received: June 22, 2005
Last Updated: June 23, 2005
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Cellerix:
ASCs (adult stem cells derived from adipose tissue)
Fistula
Cell Therapy
Complex perianal fistula

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014