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NCT04548583 · ClinicalTrials.gov registry record · Phase 1
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
A Phase 1 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04548583: Clinical Trial Phase 1 study, sponsored by The Cleveland Clinic.
NCT04548583 is a Phase 1 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548583, a Phase 1 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal colectomy for symptom control. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory Crohn's colitis.
Primary Outcome
The primary endpoint of this study is to determine the safety and feasibility of endoscopic injection of remestemcel-L, an ex vivo expanded allogeneic bone marrow-derived mesenchymal stem cell product, for treatment of medically refractory Crohn's colitis.
Interventions
- OTHER Placebo
- DRUG Remestemcel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-11-15 |
| Phase | Phase 1 |
Why NCT04548583 stopped before completion
NCT04548583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04548583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04548583 about?
NCT04548583 is a clinical study titled "Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis". Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal cole...
What is the current status of trial NCT04548583?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2020-11-04. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT04548583?
The interventions under investigation include: Placebo (OTHER), Remestemcel-L (DRUG).
Who is sponsoring clinical trial NCT04548583?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04548583's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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