A Study of a Stem Cell Fistula Plug to Treat Cryptoglandular Perianal Fistulas
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-003200
NCT ID: NCT02589119
Sponsor Protocol Number: 15-003200
About this study
The purpose of this study is to assess the safety of autologous mesenchymal stromal (stem) cell transfer using a biomatrix (the Gore Fistula Plug) to treat perianal fistula.
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
- Males and females 18-65 years of age
- Residents of the United States
- Have a single-tract, transsphincteric anal fistula of cryptoglandular origin
- Primary fistula (no previous surgical treatment)
- Those who have failed previous surgical repairs
- Have no contraindications to MR evaluations
- Pacemaker
- 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
- 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
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 Eric Dozois, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available