Status:
COMPLETED
Pediatric MSC-AFP Sub-study for Crohn's Fistula
Lead Sponsor:
Mayo Clinic
Conditions:
Fistula in Ano
Crohn Disease
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells ...
Detailed Description
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 cells...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females 12-17 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-aminosalicylate (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (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 (and assent where appropriate).
- Must have failed standard medical therapy including anti-TNF agents
- Exclusion Criteria
- Inability to obtain informed consent (and assent where appropriate).
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. sepsis, pneumonia active serious infection or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- Specific exclusions;
- a. 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 trying to become 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 adipose tissue is not technically feasible
- Weight less than 35 kg
- Allergic to local anesthetics
- Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
Exclusion
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03449069
Start Date
July 23 2018
End Date
December 31 2023
Last Update
March 13 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905