Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)
United States15 participantsStarted 2016-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
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
What they're measuring
1
Number of participants with treatment-related adverse events (safety and toxicity).