Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas (NCT03209700) | Clinical Trial Compass
CompletedPhase 1
Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas
United States7 participantsStarted 2017-07-20
Plain-language summary
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).
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 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
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)
✕
What they're measuring
1
Number of participants with treatment-related adverse events (safety and toxicity).