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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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 to coat the plug come from the patient.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

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;

a. 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)