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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). 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.
Primary Outcome
Participants will have a health assessment and blood work measured at each study visit to monitor for adverse events, such as worsening of the cryptoglandular fistulizing disease, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Interventions
- DRUG MSC-AFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-09 |
| Phase | Phase 1 |
What the finished NCT02589119 record still lists
NCT02589119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which MSC-AFP is the first listed.
NCT02589119 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02589119's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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