Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells (FISPAC)

April 17, 2018 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

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, Spain, 28046
        • Hospital Universitario La Paz
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
    • Aragón
      • Zaragoza, Aragón, Spain, 59009
        • Hospital Clinico Lozano Blesa
    • Castilla-Leon
      • Salamanca, Castilla-Leon, Spain, 37007
        • Hospital Clinico Universitario
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Hospital General Universitario

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:

  1. Signature of informed consent.

  2. Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present:

    • some degree of fecal incontinence associated
    • extrasphinterics fistulas,
    • fistulas supraresfinterianas
    • high transsphincteric fistulas.
  3. Patients of both genders, with more that 18 years.
  4. Good overall health, according to data from the clinical history and physical examination.

Exclusion Criteria:

  1. Patient diagnosed with inflammatory bowel disease.
  2. Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed.
  3. History of alcohol or substance abuse in the 6 months prior to inclusion.
  4. Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years.
  5. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
  6. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
  7. Major surgery or severe trauma of the subject in the previous semester.
  8. Pregnant or lactating women.
  9. Adult women of childbearing potential not using effective contraception during the trial.
  10. Administration of any investigational drug at present to three months prior to enrollment for this trial.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASC + fibrin glue
Intervention: drug: ASC + fibrin glue Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 100 million ASCs plus fibrin glue plus a deep curettage and closure of the internal orifice and evaluated after 16 weeks. If needed a second dose of 100 million ASCs plus fibrin glue will be applied then.
Drug: ◦Drug: ASCs. + fibrin glue
Experimental group
Other Names:
  • Experimental Drug: ASCs + fibrin glue
Active Comparator: Fibrin glue
Intervention: fibrin glue Fibrin glue: Subjects will be treated with a dose fibrin glue plus a deep curettage and closure of the internal orifice, and evaluated after 16 weeks. If needed a second dose of fibrin glue will be applied then.
Drug: fibrin glue
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/efficacy
Time Frame: 2014, march
Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) [ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose ]
2014, march

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/efficacy
Time Frame: 2015, march
Clinical complexity of fistula (complexity of fistula score) • Safety: Cumulative incidence of adverse effects. • Quality of life (SF-36 score) • Degree of anal incontinence (Wexner incontinence score) [ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose ]
2015, march

Collaborators and Investigators

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

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

  • Principal Investigator: Damián García-Olmo, Prof., Instituto de Investigación Hospital Universitario La Paz

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

February 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-001178-28

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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