A Study of a Stem Cell Fistula Plug to Treat Cryptoglandular Perianal Fistulas

Overview

About this study

The purpose of this study is to assess the safety of autologous mesenchymal stromal (stem) cell transfer using a biomatrix (the Gore Fistula Plug) to treat perianal fistula.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Males and females 18-65 years of age
  • Residents of the United States
  • Have a single-tract, transsphincteric anal fistula of cryptoglandular origin
    • Primary fistula (no previous surgical treatment) 
    • Those who have failed previous surgical repairs
  • Have no contraindications to MR evaluations
    • Pacemaker
    • Magnetically active metal fragments
    • Claustrophobia
  • Ability to comply with protocol
  • Competent and able to provide written informed consent

 

Exclusion Criteria

  • Inability to give informed consent.
  • Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
  • Specific exclusions; Evidence of hepatitis B, C, or HIV
  • History of cancer including melanoma (with the exception of localized skin cancers)
  • Investigational drug within thirty (30) days of baseline
  • A resident outside the United States
  • Pregnant or breast feeding
  • History of clinically significant auto-immunity (e.g. Crohn's disease) or any previous example of fat-directed autoimmunity
  • Previous allergic reaction to a perianal fistula plug
  • If liposuction is not technically feasible
  • Allergic to local anesthetics
  • Pregnant patients or trying to become pregnant
  • Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
  • Multi-tract, suprasphincteric and extrasphincteric fistula tract extensions
  • Active local infection associated with the fistula

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eric Dozois, M.D.

Closed for enrollment

Contact information:

Jessica Friton

(507)284-0495

Friton.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20156875

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