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NCT01915927 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Fistula Plug in Perianal Crohn's Disease
A Phase 1 study, sponsored by William A. Faubion, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01915927: Completed Phase 1 study, sponsored by William A. Faubion, M.D..
NCT01915927 is a Phase 1 study that has completed, run by William A. Faubion, M.D.. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915927, a Phase 1 study, has completed, sponsored by William A. Faubion, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® 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
The primary endpoint of this study is to determine the safety and feasibility of using adipose derived, autologous mesenchymal stromal cells (MSC) bound to the Gore® Bio-A® Fistula Plug for treatment of refractory CD perianal fistulae.
Interventions
- DRUG MSC-AFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2019-12 |
| Phase | Phase 1 |
What the finished NCT01915927 record still lists
NCT01915927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which MSC-AFP is the first listed.
NCT01915927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915927 about?
NCT01915927 is a clinical study titled "Stem Cell Fistula Plug in Perianal Crohn's Disease". The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing...
What is the current status of trial NCT01915927?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01915927?
The interventions under investigation include: MSC-AFP (DRUG).
Who is sponsoring clinical trial NCT01915927?
This trial is sponsored by William A. Faubion, M.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915927's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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