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NCT02589119 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02589119: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02589119 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02589119, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.
Interventions
- DRUG MSC-AFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02589119
The ClinicalTrials.gov registry entry for NCT02589119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 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.
NCT02589119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02589119 about?
NCT02589119 is a clinical study titled "Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)". The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will...
What is the current status of trial NCT02589119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-01. Estimated completion is 2019-09.
What interventions are being tested in trial NCT02589119?
The interventions under investigation include: MSC-AFP (DRUG).
Who is sponsoring clinical trial NCT02589119?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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