Pediatric MSC-AFP Sub-study for Crohn's Fistula

Overview

About this study

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 to coat the plug come from the patient.

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria

  1. Males and females 12-17 years of age.
  2. Residents of the United States.
  3. Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
  4. Concurrent therapies with corticosteroids, 5-aminosalicylate (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted.
  5. All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
  6. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
  7. Ability to comply with protocol
  8. Competent and able to provide written informed consent (and assent where appropriate).
  9. Must have failed standard medical therapy including anti-TNF agents

Exclusion Criteria

  1. Inability to obtain informed consent (and assent where appropriate).
  2. 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.
  3. Specific exclusions;
    1. Evidence of hepatitis B, C, or HIV
  4. History of cancer including melanoma (with the exception of localized skin cancers)
  5. Investigational drug within thirty (30) days of baseline
  6. A resident outside the United States
  7. Pregnant or trying to become pregnant, or breast feeding.
  8. History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
  9. Previous allergic reaction to a perianal fistula plug.
  10. If adipose tissue is not technically feasible
  11. Weight less than 35 kg
  12. Allergic to local anesthetics
  13. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Stephens, M.D.

Open for enrollment

Contact information:

Jessica Friton

(507)284-0495

Friton.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20410296

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