Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)

Completed · Phase 1

Conditions studied: Perianal Fistula, Cryptoglandular Perianal Fistula

In brief

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.

Key facts

Study ID

NCT02589119

Run by

Mayo Clinic

People needed

15

Starts

2016-01-01

Expected to finish

2019-09-01

Last updated by the study team

2019-12-06

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-tract, transsphincteric anal fistula of cryptoglandular origin. Primary fistulas (no previous surgical treatment) and those who have failed previous surgical repairs
• 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

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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