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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02807389
The ClinicalTrials.gov registry entry for NCT02807389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 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 Fistula Plug is the first listed.
NCT02807389 reports 0 study locations.
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.
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