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NCT02807389 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Fistula Plug in Post Surgical Leak Fistulas
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02807389: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02807389 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02807389, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 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 (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.
Primary Outcome
Data collection will include: worsening of the fistula, 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 Fistula Plug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 1 |
What the finished NCT02807389 record still lists
NCT02807389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which MSC Fistula Plug is the first listed.
NCT02807389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02807389 about?
NCT02807389 is a clinical study titled "Stem Cell Fistula Plug in Post Surgical Leak Fistulas". 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 (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks ...
What is the current status of trial NCT02807389?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2017-03-14. Estimated completion is 2019-04-02.
What interventions are being tested in trial NCT02807389?
The interventions under investigation include: MSC Fistula Plug (DRUG).
Who is sponsoring clinical trial NCT02807389?
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 NCT02807389's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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