Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

Completed · Phase 1

Conditions studied: Fistula Vagina, Crohn Disease

In brief

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. This is an autologous product derived from the patient and used only for the same patient. Participants will be in this study for two years. There is potential to continue to monitor participants' progress with regular visits as part of standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

Key facts

Study ID

NCT03220243

Run by

Mayo Clinic

People needed

5

Starts

2017-10-19

Expected to finish

2020-09-20

Last updated by the study team

2020-10-30

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females 18-65 years of age.
• Residents of the United States.
• Crohn's disease with single or multiple draining complex rectovaginal fistulae for at least three months despite standard therapy
• 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
• Currently with diverting ileostomy or accepting of diverting ileostomy at time of stem cell loaded plug placement.

You may not qualify if…

• 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.
• Allergic to local anesthetics
• Pregnant patients or trying to become pregnant.
• entero-vesicular or multiple concurrent perianal tracts

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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