Stem Cell Coated Fistula Plug in Patients With Crohn's RVF (NCT03220243) | Clinical Trial Compass
CompletedPhase 1
Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
United States5 participantsStarted 2017-10-19
Plain-language 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 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)
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Inability to give informed consent.
✕
What they're measuring
1
Number of participants with treatment-related adverse events (safety and toxicity).
. 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