Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas


About this study

This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas).

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  1. Males and females 18-65 years of age.
  2. Residents of the United States.
  3. Single draining perianal fistula for at least three months despite standard therapy
  4. Concurrent therapies are permitted (such as antibiotics, corticosteroids, thiopurines).
  5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
  6. Ability to comply with protocol
  7. Competent and able to provide written informed consent
  8. Patients that were treated with an MSC-coated fistula plug in the study IRB#12-009716 or IRB#15-003200

Exclusion Criteria

  1. Inability to give informed consent.
  2. 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.
  3. Specific exclusions: Evidence of hepatitis B, C, or HIV
  4. History of cancer including melanoma (with the exception of localized skin cancers)
  5. Investigational drug within thirty (30) days of baseline
  6. A resident outside the United States
  7. Previous allergic reaction to a perianal fistula plug.
  8. Allergic to local anesthetics
  9. Pregnant patients or trying to become pregnant or breast feeding.
  10. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

William Faubion, M.D.

Closed for enrollment

More information


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