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

Completed · Phase 1

Conditions studied: Perianal Fistula, Cryptoglandular Perianal Fistula, Crohn's Perianal Fistula

In brief

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).

Key facts

Study ID

NCT03209700

Run by

William A. Faubion, M.D.

People needed

7

Starts

2017-07-20

Expected to finish

2019-12-10

Last updated by the study team

2020-01-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Previous allergic reaction to a perianal fistula plug.
• Allergic to local anesthetics
• Pregnant patients or trying to become pregnant or breast feeding.
• Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)

Where it is running

• Mayo Clinic in Minnesota — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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