Status:
COMPLETED
Stem Cell Fistula Plug in Perianal Crohn's Disease
Lead Sponsor:
William A. Faubion, M.D.
Conditions:
Perianal Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million ce...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females 18-65 years of age.
- Residents of the United States.
- Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
- All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
- 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
- Must have failed standard medical therapy including anti-TNF agents
- 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 (other than 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 (ie recto-vaginal, entero-vesicular)
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01915927
Start Date
July 1 2013
End Date
December 1 2019
Last Update
January 3 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905