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NCT03220243 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03220243: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT03220243 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03220243, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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)
Interventions
- DRUG MSC-AFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2020-09-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03220243
The ClinicalTrials.gov registry entry for NCT03220243 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MSC-AFP is the first listed.
NCT03220243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03220243 about?
NCT03220243 is a clinical study titled "Stem Cell Coated Fistula Plug in Patients With Crohn's RVF". 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 t...
What is the current status of trial NCT03220243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2017-10-19. Estimated completion is 2020-09-20.
What interventions are being tested in trial NCT03220243?
The interventions under investigation include: MSC-AFP (DRUG).
Who is sponsoring clinical trial NCT03220243?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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